Large pharmaceutical company in need of support with Clinical Evaluation Reports (CER), Clinical Evaluation Plans (CEP), Post-Market Surveillance (PMS), and Pediatric Assessments for a variety of products on a periodic basis to meet European Union Medical Device Regulations (EU-MDR) requirements. This clinical affairs support is essential for compliance.
CHALLENGE
SOLUTION
RESULTS
- Ongoing support to meet EU-MDR clinical documentation requirements across multiple product families.
- Expertise needed to author and update CERs, CEPs, PMS reports, and Pediatric Assessments.
- Ability to manage large-volume literature reviews, incorporate evolving design/manufacturing changes, and ensure alignment with SOPs and regulatory expectations.
- Support required on accelerated timelines for Notified Body submissions.
- Delivered a fully integrated project approach, encompassing device concept, engineering design, analysis, risk management, and verification testing.
- Developed and implemented a complete manufacturing quality system compliant with CGMP, enabling in-house production of clinical trial materials.
- Authored comprehensive technical documentation, including Design History File (DHF), quality system documents, and manufacturing records.
- Seamlessly coordinated all aspects (design, prototyping, testing, and regulatory manufacturing) within the Kymanox team to eliminate delays and communication gaps.
- Met all deliverables, including those on compressed timelines.
- Completed extensive literature reviews involving hundreds of abstracts and articles per project.
- Achieved full compliance with EU-MDR, company SOPs, and relevant international standards.
- Supported all product classes, from simple disposables to complex implantables and SaMD.