Beyond the DHF: connect the medical device record
Connected product knowledge for medical devices and combination products.
Medical device development produces a large body of evidence: user needs, design inputs, design outputs, risk-management activities, verification and validation results, supplier controls, manufacturing records, nonconformances, CAPAs, complaints, and post-market information. These artifacts usually exist. The harder question is whether an organization can connect them fast enough to assess a change, investigate an event, or show the rationale behind a decision. Beyond the DHF is a vendor-neutral white paper for engineering, quality, and regulatory leaders at medical device and combination product companies.
The FDA Quality Management System Regulation (QMSR) took effect on 2 February 2026, amending 21 CFR Part 820 and incorporating ISO 13485:2016 by reference. The QMSR no longer uses terms such as “Design History File”, and ISO 13485 Clause 7.3 now describes the elements behind them. That raises the importance of traceability. For combination products, 21 CFR Part 4 adds CGMP and post-market safety-reporting requirements across drug, biologic, and device constituent parts.
What is a connected medical device record?
A connected medical device record is a governed product-evidence model that links user needs, design inputs, risk controls, design outputs, verification and validation evidence, configuration, supplier and material records, change history, and post-market information through stable identifiers and controlled relationships. It works alongside existing engineering, quality, and manufacturing systems, so teams can move from a change, complaint, or material issue to the underlying evidence and back again without rebuilding it by hand.
This matters most for complex devices and combination products that include coatings, adhesives, polymers, drug or biologic constituents, diagnostic reagents, or software. Read more on product lifecycle management and Uncountable's QMS.
Who this white paper is for
Engineering, quality, and regulatory leaders at medical device and combination product companies.
For a one-page overview of how Uncountable approaches this, read the solution brief Discrete PLM: parts, materials and test data in one PLM.
What's inside
Inside this white paper:
- Why the product record is larger than a file, and what the QMSR terminology change means for traceability
- The connected product-evidence model and the relationships it should preserve
- Why document-centered traceability falls short when a change or complaint arrives
- Combination products: where device, drug, biologic, and materials data models meet
- Change control as a lifecycle capability, with impact traced to its evidence
- Software, electronic records, Part 11, and computer software assurance
- A reference architecture, an implementation roadmap, and measures of success
Download the white paper to trace any change to its evidence.
FAQs
The FDA Quality Management System Regulation took effect on 2 February 2026, amending 21 CFR Part 820 and incorporating ISO 13485:2016 and Clause 3 of ISO 9000:2015 by reference. The QMSR no longer uses some terms from the previous Quality System regulation, including Design Change and Design History File. ISO 13485:2016 Clause 7.3 now describes the elements behind those terms, which raises the importance of connected traceability.
The white paper is for engineering, quality, and regulatory leaders at medical device and combination product companies, particularly those with complex devices that include coatings, adhesives, polymers, drug or biologic constituents, diagnostic reagents, software, or multiple manufacturing partners.
A connected product-evidence model links authoritative records, such as user needs, design inputs, risk controls, design outputs, verification and validation evidence, configuration, supplier and material records, changes, and post-market information, through stable identifiers, controlled relationships, and risk-appropriate workflows. It works alongside existing engineering, quality, and manufacturing systems rather than replacing them.
Combination products combine two or more regulated constituent parts, such as drug-device, biologic-device, or drug-device-biologic products. Their evidence spreads across engineering, formulation, analytical development, manufacturing, supplier quality, clinical, regulatory, quality, and post-market systems, and 21 CFR Part 4 sets CGMP and post-market safety-reporting requirements that span those constituent parts.
Document-centered traceability records that evidence exists, but not the live relationships between records. When a change, complaint, or material issue arrives, teams must search documents and reconcile versions by hand to see what is affected. A connected record lets them move from the event to the underlying requirements, risk controls, V&V evidence, and supplier records and back again.
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