United States
QMSR Gap Analysis
Best for: Manufacturers selling, or planning to sell, in the US.
You receive
- QMSR gap report
- Prioritized action plan
- Debrief with your team
For medical device & component manufacturers
One quality system. Every market.
ISO 13485, EU MDR, US FDA QMSR and Gulf SFDA readiness for medical device and component manufacturers. Independent internal audits, clear scope, fixed-price packages.
Frameworks we work with
- ISO 13485:2016
- 21 CFR Part 820 (QMSR)
- EU MDR 2017/745
- ISO 14971:2019
- ISO 10993-1
- ISO 11135
- ISO 11137
- ISO 14644
Choose your market
Where are you selling, or planning to sell?
Each market has its own rules, but they now share one foundation. Start with the market that matters most to you.
Priority market
United States (FDA)
FDA · QMSR, 21 CFR Part 820
Explore Priority marketEuropean Union (MDR)
Regulation (EU) 2017/745 · notified bodies
Explore Priority marketTürkiye
TİTCK · Medical Device Regulation aligned with EU MDR
Explore Phase 2Gulf (SFDA & UAE)
Saudi FDA · Medical Device Marketing Authorization
Explore Why now
Two deadlines that change the work of quality teams
US · FDA
QMSR is live since Feb 2, 2026
Internal audit reports, supplier audit reports and management reviews are now open to FDA inspection. Audits written for a drawer now need to stand up to an investigator.
Read more EU · MDRMDR transition ends 2027 / 2028
Extended MDD transition periods end on Dec 31, 2027 (Class III and IIb implantable) and Dec 31, 2028 (other devices). Notified body time is the bottleneck, not the legal date.
Read more Featured service
Your internal audits are now FDA-visible. Make them inspection-ready.
Independent, risk-based internal audits against ISO 13485, the QMSR and the EU MDR, run remotely with secure screen sharing, and reported in a way that shows a working system.
- Auditor independent from the audited work, as ISO 13485 requires
- Remote by default; on site in Türkiye and Europe
- Findings graded by risk, with CAPA recommendations
Services
All services What we do
Every service builds on the same ISO 13485 foundation, so work done for one market counts in the others.
QMSR Gap Analysis
Check your ISO 13485 system against the FDA QMSR and related US requirements, with a prioritized action plan.
DetailsISO 13485 Quality Management System
One QMS built to serve EU MDR, FDA QMSR, Türkiye and Gulf requirements: set-up, upgrade and training.
DetailsEU MDR & CE Marking
MDR transition, technical documentation, GSPR, ISO 14971 risk management and notified body preparation.
DetailsSupplier Audits in Türkiye & Europe
On-site supplier audits for US and EU manufacturers sourcing components or services from Türkiye and Europe.
DetailsValidation
Sterilization validation, test method validation, cleanroom and process validation reviews.
DetailsCAPA & Quality Processes
CAPA, nonconformance, complaints, document control, batch record review and product release.
Details Fixed-price packages
See all packages Clear scope. Clear deliverables. No hourly surprises.
All markets
Remote Internal Audit
Best for: Manufacturers under ISO 13485, FDA QMSR or EU MDR who need an independent auditor.
You receive
- FDA-presentable audit report
- Nonconformity log
- CAPA recommendations
European UnionTürkiye
MDR Transition Support
Best for: Manufacturers selling in the EU who need to complete MDR certification.
You receive
- Transition plan
- GSPR checklist
- Technical file structure
- Pre-submission review
How we work
Clear scope, visible progress
- 01
Intro call
A free 30-minute conversation about your device, target markets and current status.
- 02
Gap analysis
A written assessment of where you stand against the requirements and what is missing.
- 03
Roadmap & fixed quote
Work packages, timeline and a fixed-scope proposal. No surprise hourly bills.
- 04
Delivery & handover
We do the work with your team, train them and hand the system over.
Why RegVia
Hands-on expertise, handled with care
- Led by a certified ISO 13485:2016 lead auditor with internal audit experience
- 6+ years of hands-on QC, QA and regulatory work in medical device manufacturing
- Experience with Class IIa, IIb and Class III devices, including implantable and sterile single-use devices
- In-depth ISO 14971 risk management, from design through post-market
Confidentiality
NDA before any document exchange, secure file sharing and defined retention.
AI policy
No client document goes into an AI tool without your written consent. Final judgement is always human.
Conflict of interest
Checked before every engagement. We decline work where we cannot be independent.
Remote-first, on site when it counts
Remote by default, on site in Türkiye and Europe.
Knowledge
All articles Latest guides
FDA / QMSR
FDA QMSR: What Changed on February 2, 2026 and What It Means for Your Internal Audits
The FDA Quality Management System Regulation incorporates ISO 13485:2016 and opens internal audit, supplier audit and management review reports to inspection. What changed and how to prepare.
CE / MDRMDR Classification Rules: A Plain-Language Guide to All 22 Rules
How are medical devices classified under MDR 2017/745 Annex VIII? The differences between Class I, IIa, IIb and III, a summary of all 22 rules and common mistakes.
CE / MDRMDD to MDR Transition: Deadlines, Conditions and Roadmap
The MDR transition periods extended by Regulation 2023/607: which deadline applies to which device, the conditions for the extension and how to plan your transition.
Frequently asked questions
Do you work with US companies?
Yes. We work remotely with US manufacturers and with non-US manufacturers selling into the US, mainly on internal audits, QMSR gap analyses and CAPA. We also audit suppliers in Türkiye and Europe on site for US companies.
How do remote audits work?
We agree the agenda and evidence list in advance, then audit through video interviews and secure screen sharing of your eQMS or records. Processes that need physical observation are covered by a live video walkthrough or a short visit.
Do you use AI with our documents?
Not without your written consent. If you agree, we only use tools that do not train on customer data, and every conclusion is reviewed and signed off by a human expert.
Which manufacturers do you work with?
Manufacturers of Class I to Class III devices and their component and service suppliers, with particular experience in implantable and sterile single-use devices. If we have a conflict of interest, we say so in the intro call.
Do you guarantee FDA clearance or CE certification?
No one can. Decisions are made by FDA and notified bodies. What we guarantee is a clear scope, honest assessment and deliverables that meet the agreed standard.
Let’s map your route to market in 30 minutes
Tell us about your device, target markets and timeline. You’ll leave the call knowing which requirements apply, where your gaps likely are and what to do first.