Medical Devices

Medical Devices

Our UK team of Medical Devices / IVD experts are here to support and guide you through the complex and ever-changing regulatory landscape. With many years of experience in the industry and with notified/UK-approved bodies we offer comprehensive regulatory services to suit your business.

Our track record of working with the MHRA, various competent authorities and multiple notified/UK-approved bodies ensures we can offer you the most efficient regulatory support.

We have years of experience working with the medical device directive 93/42/EC, The In Vitro Diagnostic Directive (98/79/EC) regulation, and now the UK MDR 2002 and regulations 2017/745 and 2017/746  on Medical Devices and in vitro diagnostics in the EU.

Not only can JensonR+ support you in navigating regulatory compliance we can also support you in creating and maintaining a compliant quality management system to meet the requirements of regulations, ISO 13485, MDSAP and GxP.

The JensonR+ team is supported by an extensive regulatory network in over 90 countries; this allows us to be the one-stop shop for all things regulatory both in the UK and beyond.

Our Services
Medical Devices

Regulatory Support/
Regulatory
Intelligence

Our team are experts in regulations across several markets and can help you access critical markets for your device.

Whether you require simple guidance or are looking for support on a complex project, our professionals have a broad range of experience to draw upon.

Medical Devices

Technical
File
Authoring

Medical Device Technical files are complex, and compiling one for assessment can be daunting.

With many years of experience in both writing and assessing technical documentation, JensonR+ is your partner for documentation support/authoring.

Medical Devices

Drug Device Combination /
Ancillary Medicinal Substance Consultation

JensonR+ boasts both a strong medicines team as well as an experienced medical device team.

This combination allows us to effectively support you with your borderline products both Drug Device Combination products and medical devices with an ancillary medicinal substance.

Medical Devices

UK Responsible
Person (RP)

JensonR+ has a dedicated UKRP service.

Manufacturers outside of Great Britain must register their products with the MHRA including those to be used in the UK undergoing clinical/performance studies. We also offer EU Rep and Swiss Rep services via our sister companies in Germany and Switzerland.

Medical Devices

Quality Management System (QMS) Support

Do you need support to get your QMS compliant?

Our team of auditors can support you in developing your QMS to comply with ISO 13485, UK MDR, EU MDR, EU IVDR and MDSAP.

Medical Devices

UK Vigilance
Support

Our vigilance support doesn’t just cover medicines.

Vigilance is a key part of any product’s life cycle and our dedicated team can review, report, and maintain vigilance activities in the UK to ease your regulatory burden.

Talk to an Expert

Tom Wood
Thomas Wood
Regulatory Manager (Medical Devices)
 
BOOK A MEETING WITH TOM