Tom Wood, Regulatory Manager for Medical Devices at JensonR+, supports clients with their medical device and drug-device combination products, offering quality and regulatory assistance from early concept stages through to post-market maintenance.
He frequently collaborates cross-functionally with colleagues at JensonR+, providing medical device and general quality management expertise to pharmaceutical companies, startups, and manufacturers of borderline products.
Joining JensonR+ in May 2023, Tom brings industry experience and expertise from his previous roles as an auditor and technical expert in notified bodies. With more than 1,000 hours of lead auditor and assessor experience, he is well-equipped to assist JensonR+ clients at any stage of their product journey.
Tom believes that a robust quality management system is essential for building a successful and compliant product. He said: “By integrating quality standards early in the product journey, regulatory compliance becomes significantly easier.”
Outside of his professional role, Tom is a self-professed nerd who enjoys spending time with his young family and has interests in rugby and Formula 1.
JensonR+ services
JensonR+ Limited is a lead member of the international regulatory network regulanet®. Together, the network forms a one-stop-shop for all things regulatory in the field of medical devices both in the UK and beyond.
Services include:
Regulatory Support/Regulatory Intelligence
Our team are experts in regulations for medical devices in several markets and can help you access critical markets for your device.
Technical File Authoring
With many years of experience in both writing and assessing technical documentation, JensonR+ is your partner of choice for documentation support.
Drug Device Combination / Ancillary Medicinal Substance Consultation
We boast a strong medicines team alongside our experienced medical device team. This allows us to effectively support you with your borderline products both Drug Device Combination products and medical devices with an ancillary medicinal substance.
UKRP
JensonR+ has a dedicated UKRP service: NexTec Medical UK.
Quality Management System Support
Our team of ex-auditors can support you in developing your QMS to comply with ISO 13485, UK MDR, EU MDR, EU IVDR and MDSAP.
UK Vigilance Support
Our dedicated vigilance team can review, report, and maintain vigilance activities in the UK to ease your regulatory burden.
Article provided by Medilink Midlands Patron JensonR+.