Don Perera

Led clinical documentation and evidence-review workstreams supporting MDR lifecycle requirements, PMCF and PMS. Worked with clinical stakeholders and KOLs to align evidence, intended purpose and risk documentation.

Led drafting and review of CERs, CEPs, PMCF/PMS plans and reports, SSCPs and regulatory responses. Coordinated technical and clinical input to address evidence gaps and Notified Body questions.

Delivered a clinical study report by integrating study data and input from scientific, clinical and regulatory contributors.

Prepared clinical and post-market documentation for higher-risk devices and software-based technologies. Collaborated with technical and regulatory teams.

Developed scientific validity, clinical performance and state-of-the-art documentation for IVDR technical files. Conducted literature searches and evidence appraisal to support IVDD-to-IVDR transition.

Prepared clinical study reports and regulatory documentation, reviewed clinical data and supported responses to Notified Body questions.

Supported EU and US submissions for Class IIb and III devices, collaborating with clinical, engineering and quality teams. Reviewed literature and clinical evidence and contributed to document quality checks.

Managed clinical investigations and usability studies with engineering and senior leadership. Worked with clinicians and key opinion leaders, supported clinical evaluations and technical files, and helped build the clinical evidence base.

Led IVDR performance evaluation deliverables and coordinated evidence assessment with scientific and regulatory stakeholders. Reviewed analytical, biological and clinical data to support scientific validity and performance evaluation.

MSc in Molecular Medicine from the University of Essex.

BSc in Biological Sciences from Canterbury Christ Church University.