Aristotelesstraat 18, 1064 LD, Amsterdam
Street Victor Brauner no. 400, Bl. 1, Ap. 13, District 3, Bucharest, Romania
+31 (0) 629075858
info@regpakbiopharma.com
MEDICAL DEVICES

Medical Device Approvals & Compliance

RegPak has full range consulting capabilities across the globe, including an all-inclusive medical device consulting service offering. Our medical device consulting capabilities include all regulatory, clinical and quality compliance aspects of device, diagnostic and combination product development. We have experience with medical devices across all classes and spanning a diverse range of indications and therapeutic areas. Our emphasis on science, coupled with the technical expertise of our medical device experts, allows us to effectively communicate with regulatory authorities in support of your product.

Clinical & Safety

Clinical Evaluation Plan:

Systematic approach & strategy, including a roadmap for conducting evaluations from development to post-market surveillance.

Analysis/Appraisal of Clinical Data:

Systematically analyze, interpret, and synthesize data. Plan and document the assessment for suitability, scientific validity, and contribution to the overall dataset.

Post-Market Clinical Follow-Up (PMCF):

Identify residual risks & gather long-term clinical performance data for better understanding.

Literature Search & Review:

Identify & review relevant data obtained through literature searching to address safety, performance, side effects & risk-benefit analysis questions.

Demonstration of Equivalence:

Identify & demonstrate the equivalence of an alternative device when appropriate for technical, biological & clinical evaluation.

Device vigilance

Device vigilance is an essential component of medical device safety, ensuring that devices on the market are continuously monitored and evaluated for potential risks.

Our services include

Regulatory Roadmaps
Gap analysis of existing regulatory technical documentation
Technical documentation preparation: Clinical Evaluation Reports and Risk Management Reports to meet required standards and guidance
Device Vigilance and aggregate reporting
Corrective action for any issues highlighted by a Notified Body

Authorized Representative (AR)

As an AR under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), our experts meticulously verify technical documentation and ensure the declaration of conformity is drafted in adherence with EU standards.

Quality Systems & Regulatory Compliance

RegPak’s Quality Systems specialists help design and prepare Quality Management Systems (QMS) and SOPs compliant with Medical Device Regulations (MDR) and international regulations, support clients through European Notified Body and FDA/ISO audits as well as assistance in resolution of compliance issues.

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