Dr Mandley has 25 years of experience in the medical device industry working with a range of product types, including permanent and resorbable implantables, advanced wound care devices, radiofrequency ablation systems and their respective accessories.
David has authored multiple Technical Files to support regulatory approval (EU 2017/745 MDR) of various medical devices from Class I non-sterile products to Class III implantable devices and dressings incorporating medicinal substances. Following submission, he has consistently and successfully addressed notified body questions during reviews of technical documentation, resulting in product certification.
David has worked for a range of companies from university spin-outs to multinational organizations. David completed his doctoral research in Applied Photochemistry at Loughborough University in 1995. He is a member of the Regulatory Affairs Professional Society (RAPS).
CORE COMPETENCIES
- MDR Technical Documentation submissions
- Consultation dossiers for devices containing medicinal substances
- Implantable medical devices
- Resorbable medical devices
- Technical writing
RECENT PROJECTS
- MDR technical documentation remediation and submission for a range of Class III implantable medical devices used by neurologists
- Remediation of risk management documentation
- Successful validation of a Summary of Safety and Clinical Performance (SSCP), incorporating patient-facing sections
PUBLICATIONS
- Mandley, D. J., Wilkinson, F., Greenhill, D. C., & Spyt, T. (1996). Laser activated albumin adhesive anastomosis. Eur Assoc Cardiothorac Surg, 188.
- Birch JF, Mandley DJ, Williams SL, Worrall DR, Trotter PJ, Wilkinson F, Bell PR. Methylene blue based protein solder for vascular anastomoses: an in vitro burst pressure study. Lasers Surg Med. 2000;26(3):323-9.