Technical Expertise / Technologies

• Non-active implantable devices
• Non-active cardiovascular, vascular and neurovascular implants
• Non-active soft tissue and other implants
• Devices utilizing tissues of animal origin
• Catheters, balloon catheters, guidewires, introducers, filters and related tools
• Active non-implantable devices utilizing hyperthermia / hypothermia
• General active devices
• Devices for radiation therapy and thermotherapy
• Electrophysiology devices and cardiac mapping devices
• Diagnostic and ablation catheters
• Devices with measuring function
• Non-active non-implantable diagnostic devices
• Active non-implantable devices for cleaning, disinfection, and sterilization
• Software (impeded and software as a medical device)
• Gastroenterology / urology devices (RF catheters, endoscopy/laparoscopy accessories, biliary stent, surgical instruments)
• Cardiac stimulators, Intracardiac Ultrasound (ICE), intracardiac mapping catheters
• 3D electroanatomical intracardiac mapping systems, RF ablation generators and defibrillators
• ENT devices
• Wound care devices 
• Dermatology devices

The Team

Melissa is an experienced Regulatory Affairs Specialist, Notified Body Technical File Reviewer and Lead Auditor with over 15 years in the medical device industry, spanning regulatory strategy, global submissions, quality systems auditing, and technical file review.  Experience navigating complex global regulatory landscapes (FDA, EU MDR/MDD, Health Canada, MDSAP) and leading cross-functional teams through product development, market entry, and post-market compliance.

Key Highlights from Experience

• Notified Body Expertise: Held roles as a client manager (BSI) and project manager (DEKRA), responsible for client oversight, conducting audits and technical file reviews. Certified Lead Auditor to ISO 13485:2016, ISO 9001:2015, MDSAP, MDR with 7 years of auditing experience. 3 years of experience as a notified body technical file reviewer conducting technical file reviews for active, software, nonactive, and nonactive implantable devices. Specializing in EU regulatory compliance under MDD and MDR frameworks. Expertise in managing and reviewing technical documentation for active, software-based, nonactive, and implantable devices in alignment with EU MDR 2017/745 and related harmonized standards. Proven success in leading technical file assessments, conformity assessments, and vigilance evaluations as a Project Manager and Lead Auditor for EU Notified Bodies.  

• Regulatory and Quality Expertise: Held roles as principal engineer and senior regulatory affairs specialist (3M, Baxter Healthcare, St. Jude Medical, Abbott) supporting new product introductions and continuing engineering projects, maintaining regulatory compliance and conducting global submissions (US, Australia, Canada, EU, Brazil, Mexico, Japan, China). Extensive experience in post market surveillance and clinical evaluation

• Technical Depth:  Master’s degree in Chemistry with technical experience supporting all stages of product development, including design and software requirements, verification and validation, risk management, and human factors. Deep knowledge of international standards (ISO 13485, ISO 14971, IEC 62304, IEC 62366)

David has over 25 years of experience specializing in the medical device industry, complemented by a strong background and a master’s degree in Biomedical Engineering and regulatory compliance. Proven expertise in regulatory affairs and quality assurance with extensive knowledge of international compliance standards (e.g., ISO 13485, ISO 14971, IEC 60601-1), US FDA, and EU Notified Body requirements, including Design History File (DHF) remediation, risk management, and technical file/510(k) submissions.

Key Highlights from Experience

• Regulatory & Quality Expertise: Held roles as a Scheme Manager/Technical Specialist (BSI Group) and Risk Management Quality Engineer (RQM+), demonstrating proficiency in MDD/MDR applications, CE Marking, Change Notification approvals, and performing Technical File Assessments. Extensive experience in risk management, post-market risk assessments and Risk Management Files remediation to ISO 14971. Held leadership and coordinator roles in Corrective and Preventive Action processes. Developed ISO 13485 compliant Quality Management System policies and procedures.

• Technical Depth: Background as a Principal Engineer (St. Jude Medical) covering all phases of the product lifecycle: systems engineering, requirements development, component design (PCB, cabling), complex signal processing and analysis, software development including user interface development, verification testing, manufacturing transfer, product safety testing, managing failure/complaint investigations (CAPA), Risk Management and global regulatory submissions FDA, CE (MDD), Brazil (ANVISA) , Japan (PMDA), China (CFDA).

• Program & Project Leadership: Successfully managed large scale medical device development projects with 130+ full-time equivalent resources and overall program schedules for product development in contract design/manufacturing and large corporations (St. Jude Medical, Abbott, Phillips-Medisize). Products included drug delivery devices, EP recording systems, cardiac stimulators, Intracardiac Ultrasound (ICE), intracardiac mapping catheters, 3D electroanatomical intracardiac mapping systems, RF ablation generators and defibrillators.

Schedule an Appointment