Bringing a medical device to market requires precision, foresight, and complete regulatory alignment. As part of our regulatory affairs consulting medical device development expertise, we help manufacturers create and maintain robust Technical Files and Design Dossiers that meet stringent EU MDR and IVDR requirements while supporting global market entry. Our specialists ensure documentation consistency, traceability, and compliance from concept through post-market surveillance—laying a strong foundation for regulatory success.
Under the European Union Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (IVDR), the Technical File or Design Dossier serves as the cornerstone of your conformity assessment. It not only details the technical characteristics of your device but also demonstrates its safety, performance, and compliance throughout its lifecycle.
Our team develops and maintains Structured documentation for CE Marking under EU MDR/IVDR, aligning your device’s evidence base with regulatory expectations. We pay attention to every aspect—design inputs and outputs, risk management documentation, verification and validation data, and clinical evaluation reports. This structured approach ensures that your technical file is ready for review by Notified Bodies or competent authorities without delays or deficiencies.
Establishing a compliant Technical File or Design Dossier begins early in product development and evolves through iterative updates. Our regulatory experts integrate seamlessly into your product teams, offering hands-on guidance to streamline documentation, mitigate regulatory gaps, and prepare your submission packages for CE marking and U.S. FDA reviews.
We assist with:
Each Technical File or Design Dossier prepared under our guidance undergoes rigorous internal review to ensure accuracy, coherence, and full traceability from design input to final device release. This process gives regulatory reviewers clear, auditable evidence of your device’s compliance and technical integrity, improving the efficiency of conformity assessment and market approval timelines.
Our consultants also provide Consulting support for obtaining CE certification of medical devices, guiding teams through the complete documentation submission and interface with Notified Bodies. With this support, manufacturers minimize administrative burden and strengthen their readiness for audits and review cycles.
Our medical device regulatory consulting services are designed for manufacturers who aim to accelerate compliance without compromising scientific and technical rigor. Through proactive engagement and precise documentation practices, we help regulatory leaders maintain control over every compliance milestone.
Partner with our regulatory experts to ensure that your Technical File or Design Dossier not only satisfies current EU MDR/IVDR expectations but also aligns with global market expansion strategies. With our proven documentation systems and regulatory foresight, your organization stays compliant, confident, and competitive in an evolving global landscape.
At PM Consultants we are a group of dedicated medical writers, regulatory affairs professionals, clinical researchers, and quality
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