1factory's quality management solutions serve the complete medical device supply chain — from finished device manufacturers (OEMs), to Tier 1 and Tier 2 contract manufacturers (CMs) and parts manufacturers./p>
Supported Standards: 1factory supports all key medical device standards, including ISO 13485 (Medical Device Quality Management Systems), 21 CFR Part 11 (Electronic Records and Electronic Signatures), and FDA Quality System Regulations (QSR).
Software Validation: 1factory provides a Verification Package (including user requirements, error checks, and testing summary) to help customers easily create their own CSA (Computer Software Assurance) report and test scripts following FDA's risk-based validation guidance.
Deep Traceability: Every data point captured in 1factory includes full traceability — user ID, timestamp, equipment ID (gage/CMM), and calibration status — meeting FDA requirements for electronic records.
For Medical Device OEMs
Companies Like: Medtronic, Johnson & Johnson MedTech, Abbott, Boston Scientific, Stryker, Zimmer Biomet, Becton Dickinson (BD), Edwards Lifesciences, and Baxter International
Key Challenge: Managing complex supply chains while maintaining FDA compliance. Coordinating hundreds of suppliers who must all meet ISO 13485 requirements. Ensuring every component, from titanium screws to silicone catheters to electronic assemblies, arrives with complete traceability and documentation. Responding quickly to supplier quality issues before they impact patient safety or trigger regulatory action.
OEM Solutions:
Supplier Quality Management: Medical device OEMs source from dozens or hundreds of suppliers — contract manufacturers producing finished devices, precision machining shops creating orthopedic components, injection molders making catheter parts, and electronics manufacturers assembling diagnostic equipment. Each supplier must maintain ISO 13485 certification and comply with customer-specific requirements.
The supplier portal standardizes how suppliers submit quality documentation. Contract manufacturers upload Device History Records (DHRs) showing complete manufacturing and inspection records for each lot. Parts suppliers submit dimensional reports with full traceability — every measurement linked to the calibrated gage used, the operator who performed it, and the exact date and time of inspection. Material suppliers provide Certificates of Analysis with test results and raw material traceability.
All submissions flow through standardized templates. When suppliers upload data, the system validates completeness automatically — checking for required electronic signatures, verifying measurement data is within specification, and confirming all required fields are populated. Missing documentation triggers immediate notifications to suppliers, preventing delays in receiving inspection.
Supplier Corrective Action (SCAR): When incoming inspection identifies defective components or when field issues trace back to supplier problems, rapid corrective action is essential. The 8D problem-solving workflow guides suppliers through root cause analysis, interim containment, permanent corrective action, and verification of effectiveness. Each step requires electronic signatures from authorized personnel, creating a complete audit trail.
The system tracks SCAR metrics automatically — how quickly suppliers respond to initial notification, whether they meet corrective action deadlines, and whether problems recur. This performance data drives risk-based receiving inspection. Suppliers with excellent records receive reduced inspection, while suppliers with quality issues face 100% inspection until they demonstrate sustained improvement.
Supplier Performance Monitoring: Real-time dashboards show supplier performance across multiple dimensions: on-time delivery rate, quality acceptance rate, SCAR response time, and corrective action effectiveness. The system calculates supplier scorecards automatically, combining these metrics into overall ratings that inform sourcing decisions.
For critical suppliers, the portal provides continuous visibility. Quality managers can log in and review recent inspection results, check current SPC charts showing process capability, and verify suppliers are maintaining required Cpk values. This transparency builds confidence and catches problems early, before they escalate to customer complaints or regulatory issues.
For orthopedic component suppliers using 1factory's tabulated parts capability, OEMs gain additional confidence in change management. When design changes or quality requirement updates are needed across a product family with hundreds of configurations, suppliers can implement changes once and cascade them automatically to all affected configurations. This dramatically reduces the risk of inconsistent implementation — where some configurations get updated but others are missed — and accelerates change order execution from weeks to days.
21 CFR Part 11 Compliance for Supplier Data: Every supplier submission is captured with complete electronic records. When a contract manufacturer's quality manager approves a DHR, their electronic signature is recorded with their user ID, full name, timestamp, and meaning of the signature (e.g., "Approved for Release"). If they later attempt to modify that record, the system prevents unauthorized changes and maintains the complete audit trail showing the original entry and any attempted modifications.
Access controls ensure suppliers can only view and modify their own data. Multi-factor authentication prevents unauthorized access. Session timeouts protect against unattended workstations. All requirements from 21 CFR Part 11 — electronic signatures, audit trails, system validation, security controls — are built into the platform.
OEM Return on Investment
Supplier documentation review becomes 60% faster when all submissions arrive through standardized portals in consistent formats with validation of completeness. Engineering teams spend less time chasing missing data and more time evaluating actual quality. Supplier corrective action processing accelerates dramatically — 75% faster closure times — when suppliers work through structured workflows rather than email chains where requests get lost.
Supplier performance reporting that once required manually compiling data from multiple sources now generates automatically. Incoming inspection planning adjusts automatically based on supplier performance — excellent suppliers receive reduced inspection, while problematic suppliers face intensified scrutiny until they demonstrate sustained improvement.
Regulatory compliance improves through proactive supplier monitoring. Early identification of supplier quality issues prevents problems before they impact production or reach patients. FDA audits become less stressful because supplier qualification records, incoming inspection data, and corrective action documentation are immediately accessible with complete traceability.
For Tier-1 Medical Device Contract Manufacturers
Companies Like: Integer Holdings, Greatbatch Medical, Sanmina Corporation, Benchmark Electronics, Plexus Corp, Phillips-Medisize, TE Connectivity Medical, and Flex Medical Solutions
Key Challenge: Producing finished medical devices under contract for OEMs while maintaining ISO 13485 certification and meeting customer-specific quality requirements. Creating complete Device History Records (DHRs) for every manufactured lot with full traceability. Managing design transfer from OEMs and ensuring manufacturing processes are validated and documented. Responding to customer audits and FDA inspections with complete, immediately accessible documentation.
Tier-1 Solutions:
Manufacturing Quality Control with Deep Traceability: Every operation in medical device manufacturing must be traceable. When an operator performs in-process inspection on a catheter assembly, the system records their user ID, the date and time of inspection, which digital caliper was used (with its calibration status), and the exact measurements taken. If they used a microscope to verify weld quality, the system records which microscope and its calibration due date.
This traceability extends to process parameters. When an operator sets up an injection molding machine, they record mold temperature, injection pressure, cooling time, and other critical parameters. The system validates these are within the approved process window and requires electronic signature confirmation. If parameters drift outside specifications during production, automatic alerts notify quality and production teams immediately.
Electronic travelers guide operators through each manufacturing step. Instead of paper travelers that get marked up, lost, or damaged, digital workflows ensure consistency. Each step displays clear work instructions with photos or videos. Operators cannot advance to the next step until completing required inspections and providing electronic signatures confirming the work was performed correctly.
Inspection Records for Device History Records (DHR): ISO 13485 requires complete DHRs showing all manufacturing and inspection activities for each device or lot. 1factory captures the inspection portion of DHRs automatically as manufacturing progresses. Material receiving inspection data, in-process inspection results, and final acceptance testing flow into the inspection records without manual compilation.
When quality teams need to generate inspection records for DHR packages, the system creates complete documentation in minutes. The inspection records include all required elements: lot traceability linking finished devices to incoming component lots, operator signatures for each inspection step, measurement data with full traceability to calibrated gages, and inspection results showing conformance to specifications.
Critical is the electronic signature and date stamps. Every entry shows who performed the action and when it occurred. If an operator documented a visual inspection, the inspection record shows their name, employee ID, date, time, and the result of the inspection with any associated photos. This level of detail satisfies the most rigorous FDA audits.
Software Validation: FDA regulations require validation of computer systems used in medical device manufacturing. 1factory provides a Verification Package after every validated environment update, including detailed test documentation with user requirements, required inputs, error checks, and expected outputs. This helps customers easily create their own CSA (Computer Software Assurance) report and test scripts following FDA's risk-based validation guidance.
Customers are hosted on a separate validated instance of the system. The verification test documentation enables customers to perform risk-based testing — flexible exploratory testing for low-risk functions and formal scripted testing for high-risk functions. System changes are managed through a validated change control process, with updated verification packages provided after each release to maintain validation status throughout the system lifecycle.
Supplier Management: Contract manufacturers manage their own supply chains — sourcing raw materials, components, and subassemblies from multiple suppliers. The supplier quality module handles supplier approval and qualification, tracks incoming inspection results, manages supplier corrective actions for quality issues, and maintains approved supplier lists with current certification status.
When receiving inspection identifies a defective component lot, the system can initiate supplier corrective actions, place lots on hold pending disposition, and alert production planning about potential material shortages. Lot traceability links defective incoming materials to the specific supplier lots, enabling targeted investigations rather than broad supplier audits.
For orthopedic component suppliers using 1factory's tabulated parts capability, contract manufacturers gain significant advantages in change management. When engineering changes require updates to inspection requirements across a bone screw product family with 200+ configurations, suppliers can implement the change once and cascade it automatically to all configurations. This reduces change order lead time from weeks to days and virtually eliminates the risk of partial implementation where some configurations get updated but others are missed — a common cause of incoming inspection failures and production delays.
Quality Management System (QMS): ISO 13485 compliance requires documented procedures, work instructions, training records, and change control. The platform's QMS module manages these requirements with document control ensuring procedures are reviewed and approved before release, version control maintaining complete document history, training assignment automatically routing new or revised documents to affected personnel for review and acknowledgment, and change control tracking document revisions with impact assessments and appropriate approvals.
Audit preparation is streamlined because the system links ISO 13485 requirements directly to procedures and evidence. When auditors ask to see evidence of training on a specific procedure, the system generates reports showing all personnel who completed training, when they completed it, and which version of the document they were trained on. This evidence is always current, never requiring scrambling to compile records.
Tier-1 Return on Investment
Inspection record generation for DHR packages drops from hours to minutes. Electronic signatures and approval workflows eliminate paper-based routing that takes days. Inspection data capture is faster and more accurate when operators work from electronic travelers instead of paper documentation.
Quality improvements protect business relationships and regulatory standing. Real-time traceability means any customer inquiry about lot quality receives immediate answers rather than requiring hours of investigation. Process capability monitoring detects drift early, preventing out-of-specification production. Complete audit trails satisfy FDA inspectors, reducing warning letter risk.
The business impact extends beyond immediate time savings. Contract manufacturers win more business by demonstrating superior quality systems to prospective customers. They scale production without proportionally adding quality staff — automation and electronic workflows let existing teams handle increased volume. They protect their reputation and grow their business by delivering consistent quality with complete documentation.
For Tier-2 Medical Device Parts Manufacturers
Companies Like: Paragon Medical, Orchid Orthopedic Solutions, Tegra Medical, MicroGroup, Lake Region Medical, Cretex Medical, AccuRounds Medical Components, and Symmetry Medical
Key Challenge: Producing precision components for medical device contract manufacturers and OEMs — orthopedic implants, surgical instruments, catheter components, drug delivery parts, and diagnostic equipment components. Managing product families with hundreds of size configurations (especially common in orthopedics where bone screws, plates, and implants vary by patient size and anatomical location). Creating complete dimensional inspection reports with full traceability, managing CMM data from multiple measurement systems, proving process capability through SPC and Cp/Cpk, and responding to customer requests faster than competitors while maintaining ISO 13485 compliance.
Tier-2 Solutions:
Dimensional Inspection with Full Traceability: Medical device components demand extreme precision. A hip implant stem might have 150-300 critical dimensions, each requiring verification. Traditional manual inspection and documentation is time-consuming and error-prone. The platform automates this process while capturing complete traceability.
First Article Inspection creation starts with automated drawing markup. The ballooning engine recognizes dimensions, adds balloon numbers, and identifies critical characteristics based on tolerance tightness and GD&T requirements. For a titanium spinal rod with 200+ features requiring inspection, automated ballooning completes in minutes what would take engineers 4-6 hours manually.
Inspection plans generate automatically from ballooned drawings. The system identifies which dimensions require CMM measurement versus manual inspection, which features need special attention due to tight tolerances, and which characteristics are critical to device functionality or patient safety. Inspection frequencies and acceptance criteria are defined for each characteristic.
Tabulated Parts for Orthopedic Components: Orthopedic manufacturers produce product families with a single base design but numerous size configurations. A bone screw product line might have a base design with 50 common features, but the length and diameter vary across hundreds of configurations — pediatric sizes differ from adult sizes, cervical screws differ from lumbar screws, each requiring different critical dimensions.
Traditional quality systems require separate inspection plans for each configuration, creating hundreds of documents to maintain. When the base design changes, quality teams must update every single inspection plan — a process taking weeks and introducing errors as some plans get missed.
1factory's tabulated parts capability solves this completely. Create a single inspection plan for the entire product family. The system automatically generates the correct inspection sheet for each configuration, pulling in all common features from the base design plus the configuration-specific dimensions. When a femoral plate ships in size 120mm, the inspection sheet includes the standard hole patterns and surface finish requirements that apply to all sizes, plus the 120mm-specific length and curvature requirements.
Updates cascade automatically. If the base design adds a new surface finish requirement, that requirement appears on inspection sheets for all configurations immediately. Quality engineers maintain one inspection plan instead of hundreds, eliminating the risk of inconsistent requirements across the product family. For orthopedic parts manufacturers managing thousands of SKUs across multiple product families, this capability transforms quality planning from a bottleneck into a competitive advantage.
CMM Data Collection with Full Traceability: Coordinate measuring machines are essential for inspecting complex medical device components. The platform integrates with all major CMM brands — Zeiss, Hexagon, Mitutoyo, Keyence, PCDMIS, Faro, Brown & Sharpe — uploading measurement data automatically when programs complete.
Critical for medical devices is the traceability captured with each measurement. When a CMM completes a measurement program, the system records which specific CMM performed the measurement (with its unique equipment ID), when the measurement occurred (date and time to the second), which operator initiated the program, which calibration artifacts were used for CMM qualification, and the environmental conditions (temperature and humidity if monitored). This traceability satisfies FDA requirements for electronic records.
The data flows directly into inspection reports and statistical process control charts without manual transcription. Features are matched to ballooned drawings automatically. Out-of-tolerance conditions trigger immediate alerts to quality engineers and production supervisors. The complete measurement dataset is stored permanently with full traceability, enabling future investigations or customer inquiries.
Statistical Process Control and Process Capability: Medical device manufacturers must demonstrate process capability through statistical analysis. The platform provides real-time SPC with control charts updating as operators inspect parts, capability indices (Cp, Cpk, Pp, Ppk) calculating continuously, and trend analysis identifying process drift before parts go out of specification.
For medical devices, process validation is critical. Initial process validation requires demonstrating capability through three consecutive production runs. The system tracks validation runs automatically, calculates capability indices for each critical characteristic, and generates validation reports proving the process is capable of consistently producing parts within specification. Ongoing process validation continues throughout production, with capability monitoring ensuring the process remains in control.
Historical trending reveals patterns that predict problems. If mean dimensions are drifting upward, tool wear is likely. If variation is increasing, machine alignment may be degrading. These early warnings allow proactive intervention — replacing cutting tools before producing out-of-spec parts or scheduling machine maintenance before accuracy degrades.
Electronic Signatures and 21 CFR Part 11 Compliance: Every quality activity requires appropriate approval. When a quality engineer reviews first article inspection results and approves a part for production, their electronic signature captures their user ID, full name, date and time of approval, and meaning of the signature. The system validates they have authority to approve and enforces multi-level approval workflows for critical decisions.
Audit trails record every action. If someone queries why a dimension was measured differently on a particular lot, the audit trail shows the original measurement method, who changed it, when they changed it, and the reason documented for the change. This complete history protects against compliance issues and supports root cause investigations.
User access controls ensure personnel can only perform actions within their authority. Operators can enter inspection data but cannot approve supplier corrective actions. Quality engineers can approve procedures but cannot modify validated computer system settings. Administrators can manage user accounts but cannot modify quality records. This segregation of duties is fundamental to 21 CFR Part 11 compliance.
Customer Portal and Real-Time Visibility: Medical device OEMs and contract manufacturers increasingly demand real-time visibility into their suppliers' quality performance. The customer portal allows approved customer personnel to log in and view inspection data as parts are manufactured, access dimensional reports and SPC charts immediately upon request, download certificates of conformance and inspection reports, and review process capability indices proving manufacturing is stable and capable.
This transparency differentiates precision medical parts manufacturers from competitors still emailing PDF reports days after production. When a customer calls asking about a specific lot's quality status, suppliers can provide answers immediately rather than spending hours compiling data from multiple systems. Built-in messaging ensures clear communication and eliminates disruptive email chains and phone calls during production.
Gage Calibration Management: Measurement equipment must be calibrated regularly. The platform tracks calibration due dates for all gages, generates automatic reminders when calibration is approaching, stores calibration certificates with full traceability, and prevents use of out-of-calibration equipment by alerting operators if they attempt to use expired gages.
When FDA inspectors ask to see gage calibration records for measurements taken six months ago, the system generates reports immediately showing which gages were used, their calibration status at the time of measurement, and the calibration certificates proving they were within tolerance. This level of documentation is impossible with spreadsheet-based calibration tracking.
Quality Management System: ISO 13485 certification and ongoing compliance require comprehensive documentation. The QMS module provides document control with version history and approval workflows, training management automatically assigning documents based on roles and tracking completion, change control managing procedure revisions with impact assessment, and audit management scheduling internal audits and tracking findings to closure.
The dynamic Quality Matrix links ISO 13485 requirements directly to procedures, ensuring complete coverage. Gap analysis for certification or surveillance audits becomes straightforward — the system identifies any requirements without corresponding procedures and any procedures without recent reviews. This automation cuts audit prep time by 80%, transforming weeks of scrambling into hours of report generation.
Tier-2 Return on Investment
First Article Inspection time drops from 6 hours to 1 hour — an 83% reduction. CMM data transcription is eliminated completely, recovering 100% of time previously spent manually entering measurements. Dimensional report creation that took 2-3 hours now completes in 10 minutes. For orthopedic manufacturers with tabulated parts, quality planning time drops by 95% — one inspection plan replaces hundreds of configuration-specific plans, and design changes cascade automatically across all configurations. Gage calibration planning becomes automatic with scheduled reminders and stored certificates accessible instantly.
Quality improvements protect manufacturing reputation and customer relationships. Real-time SPC detects process drift early, preventing scrap from tool wear or machine issues. Catching problems before producing defective parts reduces scrap costs and avoids the reputation damage of delivering defective components to medical device customers. Complete traceability of every measurement to specific gages and operators satisfies customer audits and demonstrates robust quality systems.
The business impact extends to competitive advantage. Parts manufacturers win more quotes by responding faster than competitors still using manual documentation. They scale production without proportionally adding inspection staff — automation and integrated CMM data collection let existing teams handle increased volume. They build customer confidence through superior quality systems and transparent real-time reporting, differentiating themselves in a competitive market and growing their business.