MedTech
Your device through MDR, clinical and the notified body. Without loops.
We guide class I to III across the entire lifecycle, from classification to post-market surveillance, and into the US in parallel via FDA 510(k)/PMA.
Book an intro call on MedTechOverview
One mandate across the full lifecycle, EU and US in parallel.
- Device classes
- I · IIa · IIb · III
- EU framework
- MDR (EU) 2017/745
- QMS
- ISO 13485
- US market access
- FDA 510(k) / PMA
We support medical device manufacturers across Class I through III over the complete lifecycle: from classification and design controls through clinical evaluation and the conformity assessment procedure under the Medical Device Regulation (EU) 2017/745, all the way to post-market surveillance and PMCF. The same manufacturers bring products to the US market in parallel via the FDA 510(k) or PMA pathway, which requires two separate worlds of evidence. What delays projects is rarely a missing standard, but technical documentation that formally addresses every General Safety and Performance Requirement without making it audit-proof.
For decision-makers
What delays projects is rarely a missing standard, but technical documentation that demonstrates formally rather than audit-proof. Notified-body audit slots have long lead times, and planning EU and FDA in parallel means building the evidence twice, early.
Key regulations & standards
Which standards apply in which phase?
What delays projects is rarely a missing standard, it is the sequence. This is how the requirements interlock across the entire lifecycle.
- 01
Pre-clinical
- Classification (Annex VIII)
- Design controls
- Risk (ISO 14971)
- Usability (IEC 62366)
- Biocompatibility (ISO 10993)
- 02
Clinical
- Clinical evaluation (Annex XIV)
- MEDDEV 2.7/1 Rev. 4
- Clinical investigation
- 03
Regulatory & approval
- Technical documentation (Annex II/III)
- Conformity assessment (Annex IX-XI)
- Notified body
- QMS (ISO 13485)
- 04
Launch
- CE marking
- EUDAMED / UDI
- FDA 510(k) / PMA (in parallel)
- 05
Post-launch
- Post-market surveillance & vigilance
- PMCF
- Cybersecurity (IEC 81001-5-1)
Industries
What challenges shape MedTech?
EU MDR compliance across the legacy portfolio
The Medical Device Regulation (EU) 2017/745 has replaced the MDD 93/42/EEC and requires a full reassessment of legacy devices. The technical documentation under Annex II and III must substantiate every General Safety and Performance Requirement from Annex I with concrete evidence, no longer through blanket reliance on old conformity assumptions.
Higher demands on clinical evidence
The clinical evaluation under Annex XIV of the MDR and MEDDEV 2.7/1 Rev. 4 calls for considerably more evidence than under the MDD. Equivalence claims are scrutinized more strictly, and post-market clinical follow-up (PMCF) is not optional but an integral part of the Clinical Evaluation Report across the full lifecycle.
Design controls and risk management as a linked obligation
Design controls and the Design History File must be seamlessly connected to risk management under ISO 14971 and usability under IEC 62366. For software as a medical device, the development lifecycle under IEC 62304 is added on top. Missing traceability between these strands is one of the most common audit gaps.
Two separate approval worlds: EU and FDA
The EU route via the notified body and the US route via FDA 510(k), De Novo or PMA follow different logic. The 510(k) pathway rests on substantial equivalence to a predicate device, whereas the MDR conformity assessment procedure rests on demonstrating conformity against the GSPR. Anyone planning documentation for both markets must build the evidence in duplicate early on.
Notified body capacity and post-market obligations
From Class IIa onward, as well as for sterile and measuring Class I products, a notified body must be involved in the procedure, and its audit slots come with long lead times. After market entry, the MDR post-market surveillance and vigilance obligations apply immediately and must hold up in the follow-up audit.
MDR rarely fails on the regulation itself, it fails on sequence. Aligning classification, clinical evidence and notified-body capacity early turns compliance into a predictable part of development rather than a bottleneck.
Dr. Jennifer Neff · Vice President Medical Device
Why Entourage
What sets us apart from classic consultancies and freelancers.
- Industry focus100% life sciences
- Deliveryoperational, on site
- Regulatory depthGxP, FDA, EMA, MDR/IVDR
- Flexibilityproject or framework contract
- Industry focuscross-industry
- Deliverymostly strategic
- Regulatory depthgeneralist
- Flexibilitylong contract terms
- Industry focussingle niche
- Deliverysingle person
- Regulatory depthown niche
- Flexibilityday rate
Expertise
Our expertise for MedTech
Next step
Where does your project stand regulatorily?
Use our free readiness checks for a first assessment, or talk to an expert directly, without obligation.
- 100% life sciences
- 500+ projects completed
- Reply usually within one working day
Case Studies
Selected projects
Contact
Your contacts for MedTech
Dr. Jennifer Neff
Vice President Medical Device
Strategic lead for the medical device division, advising on MDR compliance, clinical evaluation and conformity obligations.
Get in touch →
Dr. Julia Beck
Head of Sales MedTec
Responsible for client relationships and the sale of tailored consulting solutions in the MedTech and IVD space.
Get in touch →FAQ
Frequently asked questions
Sources
- Regulation (EU) 2017/745 (MDR): primary text, Annex I, II, III, VIII, IX–XI, XIV
- ISO 13485:2016: Quality management systems for medical devices
- ISO 14971: Application of risk management to medical devices
- IEC 62304: Software lifecycle processes for medical device software
- IEC 62366-1: Application of usability engineering to medical devices
- ISO 10993: Biological evaluation of medical devices
- MEDDEV 2.7/1 Rev. 4: Guideline on clinical evaluation
- FDA 21 CFR 807 Subpart E (510(k)) and 21 CFR 814 (PMA)
- MedTech industry widget (medtech-widget.html, existing industry page)
- https://theentourage.de/branchen/ (industry hub, live status)
Last updated: 14 June 2026
Industries
More industries
Pharma
Hands-on support across the entire lifecycle, from drug substance research to GDP-compliant distribution. On the ground, from the shop floor to the authority dossier.
Learn more →
Biotech
From biomedical research to industrial GMP manufacturing: scale-up from lab scale to commercial production of biologics, with complete process characterization and CMC documentation.
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IVD
Through the IVDR paradigm shift in clinical evidence and performance evaluation: from assay development to the post-market phase, including portfolios with 200+ products.
Learn more →Have a concrete project?
Briefly outline your situation. We'll respond with an initial assessment, usually within one business day.
Prefer direct? +39 02 8904 1000
info@theentourage.it
- Reply usually within one working day
- 4 offices: DE · CH · IT · US
- 100% life sciences