Medical Device Regulatory Consulting
Excellence from Concept to Post-Market
Navigate EU MDR compliance, clinical development, and post-market surveillance with confidence. Our former Notified Body experts deliver end-to-end solutions for Class I-III devices.
Core Medical Device Expertise
Regulatory Strategy & Certification
- MDR Certification Support: Gap assessments, technical documentation remediation, and Notified Body liaison
- EU MDR Compliance Services: Article 120 transition strategies for legacy devices
- Medical Device Regulatory Pathway: Global submission planning (FDA 510(k), UKCA, Australia TGA)
- Drug-Device Combination Products: 21 CFR Part 4 compliance and borderline assessments
Clinical Evaluation Plan
Clinical Development & Evidence Generation
- Clinical Development Plans: ISO 14155-aligned strategies for PMCF/clinical investigations
- Biological Evaluation Reports: ISO 10993-compliant biocompatibility assessments
- Clinical Evaluation Reports (CER): MEDDEV 2.7/1 Rev 4 and MDCG compliance with state-of-the-art analysis
- Post-Market Clinical Follow-Up (PMCF): Study design, survey implementation, and real-world evidence strategies
Specialized Services
Annex II/III packages with GSPR compliance mapping
EU MDR labeling requirements & IFU validation
MDD-to-MDR transition with QMS integration
Proactive monitoring of MDR amendments
ISO 10993 biological evaluation plans & reports; Vendor selection for cytotoxicity/genotoxicity studies;
IEC 60601 compliance strategies
PMCF survey design and statistical analysis plans
MDR Compliance Roadmap
Phase 1: Pre-Submission Preparation
Phase 2: Documentation & Validation
Phase 3: Certification & Beyond
Differentiated Expertise
ex-BSI/TÜV SÜD experts
Synchronized CER/PMCF timelines, including clinical investigations, if applicable.
68% of projects involve Class IIb/III devices; 20+ combination product submissions
100% MDR submission success rate; 30% faster certification vs industry average
Challenge: Class IIb manufacturer needed urgent transition from MDD to MDR with incomplete clinical data.
Solution:
- Literature-based CER with PMCF gap analysis
- PMCF study development
- Notified Body negotiation strategy
Result: CE Mark granted in 9 months with 60% cost savings vs new trials.
Challenge: Post-market surveillance requirements for Class IIb device with limited budget.
Solution:
- Real-world evidence collection via hybrid PMCF survey
- ISO 14155-compliant registry study design
- Automated safety signal detection system
Result: Sustained compliance with 85% participant retention rate.
Frequently Asked Questions
Ask us a Question-
What's included in a biological evaluation report?
Our ISO 10993-compliant reports include material evaluation, including the type and duration of body contact, as well as potential biological risks. They include a review of existing data, material characterization, and toxicological risk assessment. Where applicable, additional testing to address required biological endpoints can be conducted – all coordinated with accredited test labs.
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How long does MDR certification typically take?
Most devices achieve certification in 6-18 months. Our phased approach reduces timelines by 40% through parallel documentation/validation processes.
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What distinguishes your PMCF services?
We implement risk-based PMCF strategies combining literature reviews, registry studies, and real-world data analytics to minimize clinical trial costs.
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What should a Clinical Evaluation Plan include?
A Clinical Evaluation Plan (CEP) is required under EU MDR 2017/745 Annex XIV, Part A, and must document the following elements:
- Device description and intended purpose — including indications, target population, and clinical claims to be substantiated
- Device classification and applicable GSPRs — specifically those requiring clinical evidence
- Description of equivalent devices (if equivalence is claimed) — including the technical, biological, and clinical characteristics used to justify equivalence
- Clinical background and state of the art — defining the current standard of care against which the device will be evaluated
- Literature search methodology — databases, search strings, inclusion/exclusion criteria, and appraisal methodology (in line with MDCG 2020-13)
- Clinical data sources to be used — own clinical investigations, PMCF data, registry data, published literature, and/or post-market surveillance data
- Acceptance criteria — defining what level of clinical evidence will be sufficient to demonstrate conformity with the relevant GSPRs
- Reference to related documents — linking to the PMCF plan, risk management file, and PMS plan
The CEP must be updated throughout the device lifecycle and reviewed as part of each periodic clinical evaluation cycle.
Accelerate Your Medical Device Compliance
Whether you’re navigating MDR certification, developing clinical evidence, or managing post-market requirements – MDx delivers turnkey regulatory success.
From Biological Evaluation to Market Success. We Deliver.
