Meeting the standards, leading the way.
Regulatory and clinical support for medical devices and IVDs
Pragmatic, customer-specific support for medical devices and IVDs — from CE marking to clinical evidence and quality systems.
What we do
Support across regulatory, clinical, validation, and delivery — from first concept to post-market.
How we work
Pragmatic, personal support aligned to your device and your regulatory reality.
Direct
No account managers or handoffs. You speak directly with your project leader.
Hands-on
We do the work with you, not just advise from the side. Practical documentation support.
Fast response
Short lines, quick answers. No waiting for committee reviews.
Every client gets a dedicated project leader who stays with the project from start to finish. This person is your single point of contact for all regulatory, clinical, and quality questions — and adapts the approach to your needs.
Learn about our approachBuilt on audit experience
Anja Wiersma PhD — Founder
CEO and Senior Consultant, mi-CE consultancy since 2010
Anja brings over 16 years of regulatory consultancy experience across pharmaceuticals, notified body certification management, and IVD manufacturing. She is a qualified lead auditor for ISO 13485, ISO 9001, MDD, IVDD, CMDCAS, and Taiwan regulatory requirements, and chaired the board of the RAPS Netherlands Chapter for 8 years and is still part of the board.
- PhD in Medical Biology (NeuroPharmaBehaviour Physiology) — University of Groningen
- 8 years in multinational pharmaceutical company — strategy and business development
- 6.5 years notified body certification management (KEMA Quality / DEKRA) — MDD and IVDD full-scope auditor
- QA/RA Director at Eurotrol BV (IVD manufacturer)
- ISO 13485 and ISO 9001 lead auditor; former CMDCAS auditor and now advises on MDSAP compliance; Taiwan regulatory compliance auditor
- Special expertise: IVDs: in-house developed IVDs/MDs; borderline products (Rule 21); combination products (including Article 117 MDR); Technical Documentation preparation for Notified Body opinion
- Chair of the Board, RAPS Netherlands Chapter (2017-2025)
Who we work with
Medtech and IVD manufacturers at every stage — from startups preparing first submissions to established companies managing regulatory transitions.
Typical client types
- Medical device manufacturers
- IVD manufacturers
- Product and regulatory teams
- Founders bringing a first device to market
- Quality managers building or improving QMS
Typical project triggers
- MDR transition planning
- IVDR technical documentation readiness
- Clinical evaluation strategy
- Risk management file setup
- Supplier audit support
- Notified body preparation
Start a conversation
Share your device type, stage, and target markets. We respond within one business day.
Common questions
Services
Support across regulatory, clinical, validation, and delivery.
Strategic Analysis
Strategy for regulatory compliance for the devices, plus market sequencing and certification choices.
View serviceContractor for Notified Bodies
MDR/IVDR compliance audits and ISO 13485 audits for notified bodies and accredited organisations.
View serviceTraining & Education
Regulatory training for manufacturers, ethics committees, clinical teams.
View serviceService comparison
| Service | When you need it | What you get | What you provide |
|---|---|---|---|
| Medical Devices | MDR transition, new CE marking, audit prep | Strategy for Regulatory Compliance analysis, gap report, remediation plan, audit pack | Existing docs, intended use, device info |
| In Vitro Diagnostics | IVDR transition, new IVD submission | Strategy for Regulatory Compliance analysis, IVDR gap report, PE checklist, readiness summary | Device info, performance data, intended purpose |
| Clinical Evidence | Evidence strategy, CER, trial planning | Evidence plan, trial review, gap analysis | Claims, existing evidence, device description |
| Strategic Analysis | Market entry, portfolio decisions | Strategy for Regulatory Compliance analysis, strategy memo, decision matrix, timeline | Product portfolio, business goals, constraints |
| Validation & Risk | Risk file, biocompat, testing plans | RMF review, test plan, biocompat plan | Device specs, materials, patient contact info |
| Project Management | Complex multi-workstream projects | Project plan, status reports, risk register | Stakeholder access, decision authority |
| QMS Systems | QMS setup, ISO certification, international markets | Gap assessment, implementation roadmap, audit prep | Existing QMS docs, scope, target markets |
| Auditing | Internal, supplier, NB preparation, clean room | Audit report, CAPA recommendations, findings | Processes, docs, facility access |
| Contractor for NBs | NB or accreditation body requiring expert audit | MDR/IVDR compliance audit, ISO 13485 audit report | Audit scope, standards, and documentation access |
| Training | Team upskilling, ethics committee support | Training session, materials, Q&A | Team size, topics, regulatory context |
Not sure which service fits
Start a conversation. We help you identify the right starting point.
Regulatory Support for Medical Devices
Structured support for CE marking under the MDR — from gap assessment to audit readiness.
What this service includes
- Review and structure technical documentation for completeness
- Support MDR Annex IX pathway compliance
- Align quality management system to ISO 13485:2016
- Conduct gap assessments and build remediation plans
- Perform internal audits and supplier audits when applicable
Typical deliverables
Strategy for Regulatory Compliance analysis
Defines the compliance pathway for your device, aligned to MDR requirements and audit expectations.
Documentation gap report
Identifies missing or incomplete sections in your technical file against MDR requirements.
Remediation plan
Prioritized action list with owners, dependencies, and timelines.
Audit preparation pack
Structured materials to prepare your team for notified body interactions.
Traceability matrix guidance
Framework linking requirements, evidence, and documentation sections.
Common pitfalls we prevent
Incomplete intended use definitions
Unclear intended use leads to misaligned risk management and clinical evaluation, causing delays during audit.
Misaligned risk and clinical evaluation
Risk management and clinical evaluation must reference each other. Disconnected files create audit findings.
Evidence not linked to claims
Every performance claim must trace to supporting evidence. Missing links are frequently flagged.
Supplier controls not evidenced
Supplier qualification records must demonstrate oversight proportional to component criticality.
What we need from you
Required
- Device description and intended use
- Current technical documentation
- QMS status and scope
- Target markets and timeline
Optional
- Previous audit reports
- Existing risk management file
- Clinical evaluation report
Ready to assess your MDR readiness
Share your device details and we will scope the work.
Regulatory Support for In Vitro Diagnostics
IVDR-aligned documentation, performance evaluation support, and QMS readiness.
What this service includes
- Align technical documentation to IVDR Annex IX
- Reference MDCG guidance, CLSI, and STED-style structures
- Support performance evaluation pathway planning
- Align QMS to ISO 13485:2016 for IVD scope
Typical deliverables
Strategy for Regulatory Compliance analysis
Defines the IVDR compliance pathway for your device, aligned to notified body expectations.
IVDR gap report
Identifies gaps against IVDR technical documentation requirements.
Performance evaluation checklist
Status tracker for analytical, clinical, and scientific performance evidence.
Audit readiness summary
Assessment of documentation maturity and open items before notified body engagement.
Common pitfalls we prevent
Missing link between purpose and claims
Intended purpose must directly connect to every performance claim. Gaps here trigger findings.
Incomplete performance evaluation
All three dimensions — analytical, clinical, scientific — must be planned and evidenced.
Weak evidence-to-labeling traceability
Labeling claims must be supported by documented evidence trails.
Clinical Research and Clinical Evidence
Strategy, trial design support, and evidence planning grounded in regulatory requirements.
What this service includes
- Develop clinical pathway strategy aligned to device claims
- Support clinical trial design and evaluation planning
- Train manufacturers on clinical evidence requirements
- Explain access pathways factually and carefully
Typical deliverables
Clinical evidence plan outline
Maps the evidence pathway from claims to required data sources.
Trial design review notes
Feedback on endpoints, populations, comparators, and study structure.
Evidence gap analysis
Identifies what evidence exists, what is missing, and how to close gaps.
Common pitfalls we prevent
Evidence not mapped to claims
Every claim needs a clear evidence trail. Unlinked claims create audit findings.
Over-reliance on literature
Literature alone may not suffice without clear justification for equivalence or applicability.
Under-specified endpoints
Vague endpoints make evidence evaluation difficult and invite challenge.
Strategic Business Analysis
Strategy for regulatory compliance for the devices, market sequencing, and certification planning.
What this service includes
- Define the regulatory compliance strategy for your devices across target markets
- Sequence market entry across EU, US, Canada, and other regions
- Provide classification reasoning support as general guidance
- Evaluate certification choices and notified body selection factors
- Analyze portfolio for time and cost reduction opportunities
Typical deliverables
Strategy for Regulatory Compliance analysis
Defines the regulatory compliance approach for your devices across target markets.
Strategy memo
Clear recommendation with rationale for market and certification sequencing.
Decision matrix
Structured comparison of options with trade-offs and dependencies.
Risk and dependency map
Visual map of regulatory risks and critical path dependencies.
Timeline assumptions
Realistic timeline model with documented assumptions and contingencies.
Common pitfalls we prevent
Starting docs before stable intended use
Documentation built on unstable intended use must be reworked. Define first, then document.
Underestimating NB lead times
Notified body capacity is limited. Plan early or risk schedule overruns.
Uncoordinated parallel workstreams
Regulatory, clinical, and quality work must be synchronized to avoid rework.
Planning your market strategy
Share your portfolio and goals. We map the path.
Validations, Biocompatibility, Risk Analysis
Risk management, product testing, biocompatibility, and labeling support.
What this service includes
- Apply risk management per ISO 14971
- Map product testing standards to claims and hazards
- Plan biocompatibility evaluation per ISO 10993 series
- Review sterility approach and packaging requirements
- Check IFU and labeling against regulatory requirements
- Provide clean room requirements guidance where relevant
Typical deliverables
Risk management file review
Structured review output covering hazard identification, risk estimation, and control measures.
Test plan mapping
Links testing requirements to specific claims and identified hazards.
Biocompatibility evaluation plan
Outlines evaluation approach based on patient contact and device characteristics.
Labeling and IFU review checklist
Systematic check of labeling against regulatory requirements and claims.
Need risk or validation support
Share your device specs and we scope the work.
Project Management
Structured delivery coordination for regulatory and quality projects.
What this service includes
- Manage project or portfolio delivery end to end
- Coordinate onsite or remote, based on project needs
- Establish communication cadence and reporting
Typical deliverables
Project plan
Milestones, dependencies, and responsibility assignments.
Weekly status report
Consistent format covering progress, blockers, and next actions.
Stakeholder action log
Tracks decisions, action items, and accountabilities across teams.
Risk register
Living document tracking project risks, mitigations, and owners.
Common pitfalls we prevent
Unowned tasks
Every task needs an owner and a deadline. Ambiguity causes delays.
Untracked dependencies
Cross-team dependencies must be visible or they become blockers.
Unsynchronized evidence creation
Evidence generation must align with documentation timelines or rework follows.
Our Approach
Pragmatic and personal — adjusted to your needs in the medical device and IVD field.
How engagement starts
Initial contact
You reach out via form, email, or chat. We respond within one business day with initial questions.
Needs investigation
We review your situation, device, stage, and goals. This takes one to two calls depending on complexity.
Quote
Clear scope, timeline, and pricing. No hidden costs. You know exactly what you get.
Dedicated project leader assigned
One person for the entire engagement. Your single point of contact for everything.
Working principles
Open communication
Direct, honest updates. No surprises. If there is a problem, you hear it immediately.
Teaching while doing
We build your team's knowledge while delivering. You gain capability, not just documents.
Pragmatic documentation
Documents that serve their purpose. Compliant, practical, and tailored to your device.
Communication cadence
Kickoff
Align on scope, timeline, responsibilities, and communication channels.
Weekly update
Short status report covering progress, blockers, and next actions.
Monthly steering (optional)
For larger projects, a broader review with stakeholders to ensure alignment.
People
Credibility through real qualifications and audit experience.
Anja Wiersma PhD
CEO and Senior Consultant, mi-CE consultancy
Anja founded mi-CE consultancy in 2010. She is a medical biologist with a PhD in NeuroPharmaBehaviour Physiology from the University of Groningen. Before entering the regulatory field she spent eight years in strategy and business development roles at a multinational pharmaceutical company. She then joined KEMA Quality (now DEKRA) as Senior Project Manager and Certification Manager, performing full-scope MDD and IVDD audits for over six years. She subsequently served as QA/RA Director at Eurotrol BV (IVD manufacturer) and is currently also QARA Manager Ad Interim at PamGene International B.V. She chaired the board of the RAPS Netherlands Chapter for 8 years and is still part of the board.
- PhD in Medical Biology (NeuroPharmaBehaviour Physiology) — University of Groningen
- 8 years in multinational pharmaceutical company — strategy and business development
- 6.5 years Sr Project Manager and Certification Manager at KEMA Quality (DEKRA) — MDD full-scope notified body auditor, IVDD full-scope auditor, ISO 13485 auditor
- Former QA/RA Director at Eurotrol BV (IVD manufacturer)
- Currently QARA Manager Ad Interim at PamGene International B.V.
- Chair of the Board, RAPS Netherlands Chapter (2017-2025)
- ISO 13485 lead auditor — endorsed by industry peers
- ISO 9001:2015 lead auditor
- Was a CMDCAS auditor and now provides advice regarding compliance with the MDSAP process
- Taiwan regulatory compliance auditor
- Special expertise: IVDs: in-house developed IVDs/MDs; borderline products (Rule 21); combination products (including Article 117 MDR); Technical Documentation preparation for Notified Body opinion
- Regulatory Affairs expertise across MDR, IVDR, MDD, IVDD and international requirements
- Experience spanning Class I through Class III devices and all IVD classes
- Over 500 professional connections in the medtech regulatory community
Our team
Beyond Anja, mi-CE works with a network of experienced specialists — all with academic backgrounds (PhD or MD level) and active professional relationships with leading hospitals and regulatory bodies.
Senior consultants
Regulatory and quality specialists with deep hands-on experience in MDR, IVDR, and international requirements.
Notified body auditors
Qualified MDD, IVDD, MDR, and IVDR auditors providing rigorous compliance reviews and audit preparation.
Medical doctors & clinical experts
Clinical specialists with access to leading hospital departments, supporting clinical evaluation and trial design.
Engagement model
Every client gets a dedicated project leader. This person is your single point of contact throughout the engagement. No handoffs, no account managers — direct access to the person doing the work.
Resources
Curated references for MDR, IVDR, and harmonised standards.
Last updated: February 2026
MDR — Medical Device Regulation
IVDR — In Vitro Diagnostic Regulation
MDCG Guidance
- MDCG endorsed guidance documents — European Commission
Guidance on MDR and IVDR implementation, classification, clinical evaluation, and more.
Harmonised Standards
NEN
- NEN — Netherlands Standardization Institute
Access to Dutch and European standards for medical devices.
Contact
Fastest path to a first conversation.
Get in touch
6675 BS Valburg
Netherlands
Prefer a structured intake
Share your device details and we prepare for the first call.
Quick question
Use the chat for routing and initial questions.
Privacy Notice
How we handle your data.
Data controller
mi-CE consultancy, The Netherlands. Contact: info@mi-ce.nl
What data we collect
Contact forms collect: name, company, email, topic, and message content. The chatbot collects: email, company, device category, intended use summary, target markets, stage, and optional fields. Website analytics collect: anonymised usage data subject to consent.
Purpose of processing
We process personal data to respond to enquiries, prepare engagement proposals, and improve our services. We do not use data for marketing without explicit consent.
Retention
Contact form and chatbot data is retained for 12 months after last contact, then deleted. Analytics data is retained according to the analytics provider's retention settings.
Processors and hosting
Website hosting, email services, and analytics providers act as processors. A current list is available on request.
Your rights under GDPR
You have the right to access, correct, delete, restrict processing, object to processing, and request portability of your personal data. Contact info@mi-ce.nl for any privacy request.
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Quality Management Systems
Setup, implementation, and compliance support across all major QMS standards.
What this service includes
- ISO 13485:2016 — full implementation, gap assessment, and certification preparation
- MDSAP ISO 13485 — Multi-Jurisdictional Audit Programme (US, Canada, Brazil, Japan, Australia)
- ISO 9001:2015 — QMS implementation and compliance for device-adjacent organisations
- FDA 21 CFR 820 — Quality System Regulation alignment for US market access
- Canadian CMDCAS — Quality system requirements for Health Canada device licences
- Taiwan regulatory requirements — QMS alignment for Taiwan market entry
- Internal QMS audits and management review preparation
Typical deliverables
QMS gap assessment
Structured review of your current system against the target standard, with prioritised gap list.
Implementation roadmap
Step-by-step plan to close gaps, assign owners, and reach certification readiness.
Process documentation
SOPs, work instructions, and forms aligned to the target standard and your operations.
Audit preparation package
Structured materials and coaching to prepare your team for external certification audits.
Standards and frameworks supported
Device QMS
- ISO 13485:2016
- MDSAP ISO 13485
- FDA 21 CFR 820
- MDR Annex IX QMS requirements
- IVDR Annex IX QMS requirements
International and sector-specific
- ISO 9001:2015
- Canadian CMDCAS
- Taiwan regulatory QMS requirements
Need QMS setup or compliance support
Tell us your target standard and current state. We scope the work.
Auditing
Internal audits, supplier audits, clean room audits, and notified body preparation.
What this service includes
- Internal QMS audits against ISO 13485, ISO 9001, MDR, and IVDR requirements
- Supplier and subcontractor audits — proportionate to risk and criticality
- Clean room qualification and environmental monitoring audits
- Production and validation audits
- Notified body preparation — mock audits and readiness assessments
- MDR Annex II and IX compliance audits
- IVDR Annex IV and VII compliance audits
- CMDCAS and Taiwan audit preparation
Typical deliverables
Audit report
Structured findings document with non-conformities, observations, and positive practices.
CAPA recommendations
Actionable corrective and preventive action proposals linked to root cause analysis.
Supplier qualification assessment
Evaluation of critical suppliers against defined qualification criteria.
NB readiness summary
Assessment of documentation and process maturity before notified body engagement.
Common pitfalls we prevent
Underprepared for notified body audits
Mock audits reveal gaps before they become official findings, protecting your timeline.
Weak supplier controls
Supplier qualification records must demonstrate oversight proportional to component criticality.
Unresolved internal audit findings
Open CAPAs from internal audits are a red flag for external auditors. They must be tracked and closed.
Audit programme gaps
The audit programme must cover all processes within QMS scope — gaps are a non-conformity in themselves.
Need audit support
Tell us the scope, standard, and timeline. We prepare and execute.
Contractor for Notified Bodies
Audit services for notified bodies and accreditation bodies on a contractor basis.
What this service includes
- MDR and IVDR compliance audits on behalf of the notified body
- ISO 13485 audits for notified bodies and accredited organisations
- QMS audits against ISO 13485 and MDR/IVDR Annex IX
- Accreditation body compliance reviews
Scope of review work
MDR/IVDR compliance audit
Audit execution aligned to notified body expectations and regulatory annexes.
ISO 13485 audit report
Audit report structured for accredited organisations and certification bodies.
QMS audit
On-site or remote QMS audit against ISO 13485 and applicable regulatory annexes.
Compliance audit report
Formal audit report in the format required by the notified body, including findings and conclusions.
Why use mi-CE for contractor review work
Anja Wiersma spent 6.5 years inside a notified body (KEMA Quality / DEKRA), performing full-scope MDD and IVDD audits. She understands notified body processes, documentation standards, and audit expectations from the inside. mi-CE brings the same rigour to contractor review work.
Notified body looking for a contractor reviewer
Contact us to discuss scope, qualification, and availability.
Training & Education
Regulatory and clinical training for manufacturers, ethics committees, and clinical teams.
What this service includes
- Regulatory training for manufacturer teams — MDR, IVDR, QMS, and clinical evidence requirements
- Ethics committee training and support on clinical investigation requirements
- Clinical evidence requirements training for product managers and R&D teams
- Compliance workshops tailored to your product area and regulatory stage
- Onsite or remote delivery, single session or series
Typical training topics
MDR / IVDR essentials
Overview of regulatory requirements, classification, conformity assessment routes, and key obligations.
Clinical evidence under MDR
Clinical evaluation process, CER structure, PMCF, and equivalence requirements.
ISO 13485 QMS fundamentals
Quality management principles, process approach, and audit readiness.
Ethics committee support
Clinical investigation requirements, informed consent, safety reporting, and regulatory interactions.
Looking for regulatory training
Tell us your team size, topics, and goals. We design the session.
News & Updates
Regulatory developments, guidance updates, and mi-CE news.
Last updated: February 2026
Recent regulatory developments
- MDCG guidance updates — European Commission Check the MDCG page regularly for new and updated guidance documents on MDR and IVDR implementation.
- MDR 2017/745 — transition period extensions and derogations remain active for selected device categories. Check EUDAMED registration requirements for your device class.
- IVDR 2017/746 — Class C transition deadline: May 2025. Class B: May 2026. Ensure notified body contracts are in place.
mi-CE updates
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