Meeting the standards, leading the way.
Direct, high-quality support for CE marking, clinical evidence, and quality systems. One dedicated project leader per client.
Support across regulatory, clinical, validation, and delivery — from first concept to post-market.
Technical documentation, MDR pathway support, QMS alignment, and audit preparation.
IVDR technical documentation, performance evaluation support, and QMS alignment.
Clinical pathway strategy, trial design support, and evidence gap analysis.
Market sequencing, classification guidance, certification choices, and portfolio analysis.
Risk management, biocompatibility evaluation, product testing, and labeling review.
Delivery management, stakeholder coordination, and reporting.
ISO 13485, MDSAP, ISO 9001, FDA 21 CFR 820, and hospital QMS setup and compliance.
Internal audits, supplier audits, clean room audits, and notified body preparation.
Technical file reviews, design dossier reviews, and MDR/IVDR compliance audits on behalf of notified bodies.
Regulatory training for manufacturers, ethics committees, and clinical teams.
One contact person. Direct communication. Fast response.
No account managers or handoffs. You speak directly with your project leader.
We do the work with you, not just advise from the side. Practical documentation support.
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.
Learn about our approach
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 chairs the RAPS Netherlands Chapter.
Medtech and IVD manufacturers at every stage — from startups preparing first submissions to established companies managing regulatory transitions.
Share your device type, stage, and target markets. We respond within one business day.
Support across regulatory, clinical, validation, and delivery.
Technical file reviews, design dossiers, MDR/IVDR audits for NBs.
View serviceRegulatory training for manufacturers, ethics committees, clinical teams.
View service| Service | When you need it | What you get | What you provide |
|---|---|---|---|
| Medical Devices | MDR transition, new CE marking, audit prep | Gap report, remediation plan, audit pack | Existing docs, intended use, device info |
| In Vitro Diagnostics | IVDR transition, new IVD submission | 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 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 review | Technical file or design dossier review report | Submission dossier, scope of review |
| Training | Team upskilling, ethics committee support | Training session, materials, Q&A | Team size, topics, regulatory context |
Start a conversation. We help you identify the right starting point.
Structured support for CE marking under the MDR — from gap assessment to audit readiness.
Identifies missing or incomplete sections in your technical file against MDR requirements.
Prioritized action list with owners, dependencies, and timelines.
Structured materials to prepare your team for notified body interactions.
Framework linking requirements, evidence, and documentation sections.
Unclear intended use leads to misaligned risk management and clinical evaluation, causing delays during audit.
Risk management and clinical evaluation must reference each other. Disconnected files create audit findings.
Every performance claim must trace to supporting evidence. Missing links are frequently flagged.
Supplier qualification records must demonstrate oversight proportional to component criticality.
Share your device details and we will scope the work.
IVDR-aligned documentation, performance evaluation support, and QMS readiness.
Identifies gaps against IVDR technical documentation requirements.
Status tracker for analytical, clinical, and scientific performance evidence.
Assessment of documentation maturity and open items before notified body engagement.
Intended purpose must directly connect to every performance claim. Gaps here trigger findings.
All three dimensions — analytical, clinical, scientific — must be planned and evidenced.
Labeling claims must be supported by documented evidence trails.
Strategy, trial design support, and evidence planning grounded in regulatory requirements.
Maps the evidence pathway from claims to required data sources.
Feedback on endpoints, populations, comparators, and study structure.
Identifies what evidence exists, what is missing, and how to close gaps.
Every claim needs a clear evidence trail. Unlinked claims create audit findings.
Literature alone may not suffice without clear justification for equivalence or applicability.
Vague endpoints make evidence evaluation difficult and invite challenge.
Market sequencing, classification guidance, and certification planning.
Clear recommendation with rationale for market and certification sequencing.
Structured comparison of options with trade-offs and dependencies.
Visual map of regulatory risks and critical path dependencies.
Realistic timeline model with documented assumptions and contingencies.
Documentation built on unstable intended use must be reworked. Define first, then document.
Notified body capacity is limited. Plan early or risk schedule overruns.
Regulatory, clinical, and quality work must be synchronized to avoid rework.
Share your portfolio and goals. We map the path.
Risk management, product testing, biocompatibility, and labeling support.
Structured review output covering hazard identification, risk estimation, and control measures.
Links testing requirements to specific claims and identified hazards.
Outlines evaluation approach based on patient contact and device characteristics.
Systematic check of labeling against regulatory requirements and claims.
Share your device specs and we scope the work.
Structured delivery coordination for regulatory and quality projects.
Milestones, dependencies, and responsibility assignments.
Consistent format covering progress, blockers, and next actions.
Tracks decisions, action items, and accountabilities across teams.
Living document tracking project risks, mitigations, and owners.
Every task needs an owner and a deadline. Ambiguity causes delays.
Cross-team dependencies must be visible or they become blockers.
Evidence generation must align with documentation timelines or rework follows.
Direct approach. One contact person. Fast response.
You reach out via form, email, or chat. We respond within one business day with initial questions.
We review your situation, device, stage, and goals. This takes one to two calls depending on complexity.
Clear scope, timeline, and pricing. No hidden costs. You know exactly what you get.
One person for the entire engagement. Your single point of contact for everything.
Direct, honest updates. No surprises. If there is a problem, you hear it immediately.
We build your team's knowledge while delivering. You gain capability, not just documents.
Documents that serve their purpose. No over-engineering. Compliant and practical.
Align on scope, timeline, responsibilities, and communication channels.
Short status report covering progress, blockers, and next actions.
For larger projects, a broader review with stakeholders to ensure alignment.
Credibility through real qualifications and audit experience.
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 chairs the Board of the RAPS Netherlands Chapter since 2017.
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.
Regulatory and quality specialists with deep hands-on experience in MDR, IVDR, and international requirements.
Qualified MDD, IVDD, MDR, and IVDR auditors providing rigorous compliance reviews and audit preparation.
Clinical specialists with access to leading hospital departments, supporting clinical evaluation and trial design.
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.
Curated references for MDR, IVDR, and harmonised standards.
Last updated: February 2026
Fastest path to a first conversation.
Share your device details and we prepare for the first call.
Use the chat for routing and initial questions.
How we handle your data.
mi-CE consultancy, The Netherlands. Contact: info@mi-ce.nl
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Setup, implementation, and compliance support across all major QMS standards.
Structured review of your current system against the target standard, with prioritised gap list.
Step-by-step plan to close gaps, assign owners, and reach certification readiness.
SOPs, work instructions, and forms aligned to the target standard and your operations.
Structured materials and coaching to prepare your team for external certification audits.
Tell us your target standard and current state. We scope the work.
Internal audits, supplier audits, clean room audits, and notified body preparation.
Structured findings document with non-conformities, observations, and positive practices.
Actionable corrective and preventive action proposals linked to root cause analysis.
Evaluation of critical suppliers against defined qualification criteria.
Assessment of documentation and process maturity before notified body engagement.
Mock audits reveal gaps before they become official findings, protecting your timeline.
Supplier qualification records must demonstrate oversight proportional to component criticality.
Open CAPAs from internal audits are a red flag for external auditors. They must be tracked and closed.
The audit programme must cover all processes within QMS scope — gaps are a non-conformity in themselves.
Tell us the scope, standard, and timeline. We prepare and execute.
Expert review services for notified bodies and accreditation bodies on a contractor basis.
Structured assessment of device technical documentation against MDR Annex II and III requirements.
Detailed review of design history, risk management, clinical evidence, and V&V documentation.
On-site or remote QMS audit against ISO 13485 and applicable regulatory annexes.
Formal audit report in the format required by the notified body, including findings and conclusions.
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.
Contact us to discuss scope, qualification, and availability.
Regulatory and clinical training for manufacturers, ethics committees, and clinical teams.
Overview of regulatory requirements, classification, conformity assessment routes, and key obligations.
Clinical evaluation process, CER structure, PMCF, and equivalence requirements.
Quality management principles, process approach, and audit readiness.
Clinical investigation requirements, informed consent, safety reporting, and regulatory interactions.
Tell us your team size, topics, and goals. We design the session.
Regulatory developments, guidance updates, and mi-CE news.
Last updated: February 2026
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