About Tom Wood

Tom joined JensonR+ in May 2023 as a Regulatory Manager – Medical Devices. He has experience in notified bodies as an auditor and technical expert and has worked in both CE and UKCA marking alongside ISO 13485, ISO 9001 and MDSAP.

MDR transition deadline for borderline devices

2024-03-15T11:30:01+00:00March 14th, 2024|

“Thank God I can use my MDD Class I Medical App until 2028!” This is a sentence we often hear, but realise that manufacturers are not aware of the fact that this is subject to certain conditions. Find out how we can help.

Combination Products

2024-02-15T15:10:16+00:00February 20th, 2024|

Combination products have complex regulatory pathways. Changes to EU regulations mean the way Drug-Device Combination products are regulated now involves notified bodies. With strong medicines and medical device teams, read how JensonR+ are expert in supporting combination products.

DDC Case Study

2024-01-18T14:16:09+00:00January 19th, 2024|

Read how JensonR+ supported an established pharmaceutical company based in the EU launching a new drug-device combination product in Europe and the UK.

Medical Device QMS Compliance and Misconceptions

2024-01-18T15:58:51+00:00January 4th, 2024|

ISO13485:2016 has now been mandatory for nearly 5 years. Due to advancements in technology, changes in political environments and the regulatory landscape it’s not surprising some working groups are looking into potential updates to the standard. Even now, 8 years after publication many manufacturers and other organisations that are certified to ISO 13485:2016 make the same common errors. Issues can result in product disapproval, delayed release, and increased cost to the business due to additional audits or recalls. Here are some Medical Device Compliance misconceptions and common mistakes that can be avoided.

Launching NexTec Medical UK

2023-10-09T12:13:54+01:00September 19th, 2023|

We are excited to announce the launch of the new Nextec Medical UK website. Part of the Jenson Group of companies, NexTec Medical offers UKRP services, post-market surveillance and vigilance services for medical devices and in vitro diagnostics in the UK.

Regulatory Rabbit Hole

2024-01-18T15:13:05+00:00August 1st, 2023|

Tom Wood navigates through a regulatory rabbit hole - a series of searches through standards and regulations in search of a definitive answer to a very specific question. Each step leads to another cryptic reference and a reference to another piece of legislation or MDCG document.

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