How do you run a research and development project so that regulatory compliance grows alongside it from the feasibility study through verification and validation, instead of being reconstructed at the end?
We support development and engineering across the entire lifecycle: from the feasibility study through design controls under ISO 13485:2016 Section 7.3 and FDA 21 CFR Part 820.30, usability engineering under IEC 62366-1:2015 and software development under IEC 62304, all the way to verification and validation and the IVD performance evaluation under EU 2017/746. The real hurdle is rarely the individual discipline, but the sequence: anyone who links requirements, risk management under ISO 14971 and evidence planning only shortly before approval ends up reconstructing traceability backwards instead of leading it forward.
- Pharma
- Biotech
- MedTech
- IVD
Overview
What requirements does regulated development place on R&D and engineering?
Support from the feasibility study through verification & validation · ISO 13485:2016 Section 7.3, FDA 21 CFR Part 820.30, IEC 62366-1:2015, IEC 62304, ISO 14971
Last updated: 2026-06-13
Research, development and engineering in pharma, biotech, MedTech and IVD are not a free space for invention, but a process whose evidence must be generated from the outset. In practice, projects rarely get stuck on the technology, but on the missing integration of requirement, risk and evidence. Four recurring levers:
- Design controls under ISO 13485:2016 Section 7.3 and FDA 21 CFR Part 820.30 require end-to-end traceability from user needs through design inputs to the verification record, as well as a complete Design History File under FDA 21 CFR Part 820 that is available as a coherent whole during inspection.
- Software and usability are risk sources in their own right: the software lifecycle under IEC 62304 and the usability engineering process under IEC 62366-1:2015 feed inputs into risk management under ISO 14971, but do not replace it.
- Biocompatibility is assessed under ISO 10993-1:2018 as part of risk management, not as an isolated material test; the chemical characterization under ISO 10993-18 governs which biological endpoints actually need to be tested at all.
- For in vitro diagnostics, the evidence rests on the performance evaluation under EU 2017/746 with its three pillars of scientific validity, analytical performance and clinical performance, consolidated in the Performance Evaluation Report; clinical performance is often the largest evidence gap.
Services
How we support you
Feasibility Studies
Early assessment of technical feasibility, regulatory pathway and evidence needs before development budget is committed. The result is a documented feasibility report with classification and pathway assumptions as the basis for the design inputs.
Learn more →Design Controls & Traceability
Building the design controls process under ISO 13485:2016 Section 7.3 and FDA 21 CFR Part 820.30 with design reviews at defined milestones and an end-to-end traceability matrix that links every requirement to its evidence and the Design History File.
Learn more →Usability & Software Engineering
Usability engineering process under IEC 62366-1:2015 with a Usability Engineering File and software development under IEC 62304 for Software as a Medical Device (SaMD), both fed back into risk management under ISO 14971 and the technical documentation.
Learn more →Biocompatibility & Material Evaluation
Biological evaluation under ISO 10993-1:2018 within risk management, governed by the chemical characterization under ISO 10993-18, with a testing plan that addresses only the biological endpoints that are actually required.
Learn more →Verification & Validation
V&V plans under ISO 13485:2016 Section 7.3 and FDA 21 CFR Part 820.30 (verification against the design inputs, validation against the user needs) as well as qualification and validation in the GMP environment under EU GMP Guide Annex 15, with each protocol tied to the traceability matrix.
Learn more →IVD Performance Evaluation
Performance evaluation for in vitro diagnostics under EU 2017/746 with its three pillars of scientific validity, analytical performance and clinical performance, consolidated in the Performance Evaluation Report and integrated into the technical documentation.
Learn more →How we work together
What it comes down to
Regulated development is a question of sequence, not of the individual discipline. The feasibility study determines which regulatory pathway and which evidence needs apply; from these arise the design inputs, which under ISO 13485:2016 Section 7.3 and FDA 21 CFR Part 820.30 must be traceable through to the verification record. Software under IEC 62304, usability under IEC 62366-1:2015 and biocompatibility under ISO 10993-1:2018 are not parallel strands here, but inputs into the same risk management under ISO 14971. Anyone who ties one of these strands to traceability too late loses it as a bottleneck, usually clinical performance for IVD or the evidence that identified risks were actually verified.
This is exactly where we come in: verification tests against the design inputs, validation against the user needs, and both hang on the same Design History File, which under FDA 21 CFR Part 820 must be available as a coherent whole during inspection. Anyone who maintains this archive continuously instead of reconstructing it at the end shifts the effort forward, into the phase in which corrections are inexpensive, rather than into the audit, where missing traceability holds up the project.
Our approach
Our approach
Step
Result
Feasibility & Pathway Assumptions
Documented feasibility report covering technical feasibility, regulatory pathway and evidence needs as the basis for the design inputs.
Design Inputs & Traceability
Complete, verifiable design inputs derived from the user needs; traceability matrix established and linked to risk management under ISO 14971.
Engineering & Risk Assessment
Design outputs, software under IEC 62304 and usability under IEC 62366-1:2015 developed; biocompatibility assessed under ISO 10993-1:2018.
Verification
Evidence that the design outputs meet the design inputs; verification protocols linked in the traceability matrix.
Validation & Performance Evidence
Validation against the user needs; for IVD, performance evaluation under EU 2017/746 consolidated in the Performance Evaluation Report.
Design Transfer & Documentation
Handover to production with qualification under EU GMP Guide Annex 15; Design History File complete and inspection-ready.
Common pitfalls
Where projects commonly fail
Traceability is reconstructed only shortly before approval.
Anyone who does not continuously maintain the link from user needs through design inputs to the verification record ends up building the Design History File under FDA 21 CFR Part 820 backwards; this is the most common reason for findings in inspection and audit.
Risk management and development run in parallel instead of interlocked.
Software under IEC 62304 and usability under IEC 62366-1:2015 generate their own risks; if these are not fed back into risk management under ISO 14971, a gap arises between the identified risk and the verification record.
Biocompatibility testing starts without chemical characterization.
Anyone who has all biological endpoints tested across the board under ISO 10993-1:2018, instead of governing them through the characterization under ISO 10993-18, ties up time and material on tests that the risk process does not even require.
V&V is planned against the wrong reference.
Verification tests against the design inputs, validation against the user needs; if the two are conflated, the evidence that the product meets the original need is missing in the end; a recurring gap under ISO 13485:2016 Section 7.3 and FDA 21 CFR Part 820.30.
For IVD, clinical performance is addressed too late.
The performance evaluation under EU 2017/746 rests on three pillars; scientific validity and analytical performance are often in place, while clinical performance remains an open evidence gap and holds up the Performance Evaluation Report.
FAQ
Frequently asked questions
Sources
- Regulation (EU) 2017/745 (MDR), primary text
- Regulation (EU) 2017/746 (IVDR), primary text, incl. performance evaluation
- ISO 13485:2016 Section 7.3 (Design and Development of Medical Devices)
- FDA 21 CFR Part 820 / 820.30 (Quality System Regulation and Design Controls)
- IEC 62366-1:2015 (Usability); IEC 62304 (Software Lifecycle); ISO 14971 (Risk Management); ISO 10993-1:2018 (Biological Evaluation)
- EU GMP Guide Annex 15 (Qualification and Validation)
- https://theentourage.de/research-development-engineering/ (existing page content, revised)
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Case Studies
What this looks like in practice
Related insights
All insights →Regulations & standards considered
- EU 2017/745 (MDR)
- EU 2017/746 (IVDR)
- MDR Annex I (General Safety and Performance Requirements, GSPR)
- ISO 13485:2016 Section 7.3 (Design and Development of Medical Devices / Design Controls)
- FDA 21 CFR Part 820.30 (Design Controls)
- FDA 21 CFR Part 820 (Quality System Regulation, incl. Design History File)
- IEC 62366-1:2015 (Application of Usability Engineering to Medical Devices)
- IEC 62304 (Software Lifecycle Processes for Medical Device Software)
- ISO 14971 (Application of Risk Management to Medical Devices)
- ISO 10993-1:2018 (Biological Evaluation of Medical Devices within a Risk Management Process)
- ISO 10993-18 (Chemical Characterization of Materials)
- EU GMP Guide Annex 15 (Qualification and Validation)
Related topics
Design Controls →
The control process under ISO 13485:2016 Section 7.3 and FDA 21 CFR Part 820.30 in detail
Verification & Validation →
V&V plans and qualification as evidence of conformity
Usability Engineering →
Usability under IEC 62366-1:2015 as a risk source in its own right
IVD Performance Studies →
Performance evaluation under EU 2017/746 with the three pillars of evidence
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