MDR-Compliance & clinical Strategy
Matern Consulting offers expert support throughout every stage of the clinical development process.
With our combination of regulatory expertise and pragmatic solutions, we ensure that your products successfully navigate the regulatory approval process.
Clinical Evaluation (CEP & CER)
My work focuses on creating and updating MDR-compliant clinical evaluations. I do not produce standard documents, but rather customized, evidence-based justifications.
Development of Clinical Evaluation Plans (CEP): Strategic planning of clinical evidence generation.
Clinical Evaluation Reports (CER): Professionally prepared in accordance with the MDR.
Gap analyses: Reviewing existing documentation for compliance and identifying areas for improvement.
Notices and Updates: Technical support for product changes, including user manuals, brochures, or product specifications.
PMCF-Strategy & Planning
Post-market clinical follow-up (PMCF) should not be an end in itself, but rather a targeted measure designed to fill data gaps.
PMCF Plans: Creating plans specifically designed to bridge identified gaps.
PMCF-Reports: Systematic processing of collected data for annual updates.
Streamlining Efforts: Strategic guidance on when existing clinical data is sufficient and when additional studies are essential.
Teaching & Inhouse-Training
Knowledge transfer is the key to lasting compliance. I equip your team with the expertise needed to navigate MDR requirements.
Topic-Specific Workshops: Practical training for the creation of Clinical Evaluations.
Avoiding Common Pitfalls: Training based on real-world deficiency lists (anonymized) and review experience.
Individual Coaching: Guiding your employees through the creation of their own documents (“Training on the Job”).
Strategic Consulting & Review
Benefit from an expert “Second Opinion” to review your documentation prior to Notified Body submission.
Pre-Submission Review: Review of your Clinical Evaluation from a reviewer’s perspective to eliminate potential deficiencies in advance.
Communication with Notified Bodies: Support in responding to inquiries or deficiency reports.
Data Strategy: Consulting on the optimal integration of preclinical data, equivalence assessments, and clinical evidence.
Our Quality Commitment
Driven by Efficiency: By investing in a solid strategy now, we eliminate friction during implementation and accelerate the review process later.