Paul Risborough, who joined NAMSA in June 2021, has over 25 years’ experience in the medical device industry, working with many active medical device technologies. Paul began his medical device career as an Electronics Technician supporting the design and manufacture of syringe pumps. He stayed in the infusion device industry for several years, developing the Alaris range of syringe pumps and large volume pumps as an Electronics Design Engineer, Production Engineer and an Electronics Engineering Manager. Paul then moved to Integra Neuro Sciences as Production Engineering Manager before moving to ML Electronics as Medical Project Leader. Mr. Risborough’s regulatory career began when he joined BSI as an Active Device Product Specialist in 2011, and in 2013, Paul was appointed as part of the BSI Active Implantable Medical Device (AIMD) Team and in 2015, was promoted to the Global Head of Active Implantable Medical Devices.

 CORE COMPETENCIES

• Design, manufacture, and regulation of Active Devices, including syringe pumps, large volume pumps; RF, ultrasonic and gas plasma surgical tools; needle-free injectors and SpO2 meter
• Regulation of Active Implantable Devices, including Left Ventricular Assist Devices (LVADS), neuromodulation (DBS, DRG, SCS, SNS, PNS, VNS), CRT/ICDs, continuous glucose monitors and brachytherapy products

• Notified Body (BSI NB 2797) trained and ISO 13485 and technical documentation assessor
• Construction of MDR-compliant technical documentation files
• Development of Medical Device Regulation (MDR) regulatory and clinical strategies
• Responding to Notified Body questions and non-conformities
• Risk management to ISO 14971, including the application of FMEA and FTA
• High knowledge of software lifecycle management to EN 62304

RECENT PROJECTS

• MDR technical documentation remediation and Notified Body submission support for a range of neurological devices, including deep brain and subdural electrodes
• Developing MDR-compliant PMS plans, PMCF plans, PMCF surveys, PMCF reports and PSUR for various active and non-active devices
• Assessment of the Clinical Evaluation Report and MDR regulatory strategy development for a novel drug delivery system
• Developing an MDR-compliant equivalency rationale for a patient cooling/warming system
• Writing MDR-compliant Instructions for Use documents
• Addressing Notified Body clinical and technical questions during certification assessments of various active and non-active devices