How can JensonR+ help you?

Are you looking for medical device help and guidance in the UK or EU?

Let the experts at JensonR+ Limited guide you through the complex landscape of regulations and territorial obligations.

We provide regulatory intelligence in a way that is clear and easy to understand.

We can help you protect your position and we can ensure you are making the most out of your products/devices.

We provide expert services to clients ranging from Inventors to SME’s all the way up to Large Pharma and Corporate Lawyers.

We can help you in some of the following areas, and many more besides:

Legal Manufacturers and Economic Operators

Obligations and strategic advice

We can explain your regulatory obligations in various areas of medical device regulation in the UK and EU and make sure you have everything covered. (CE, UKCA, UKNI, marking)

Regulatory Technical Support

UK MDR 2002, MDR 2017/745, IVDR 2017/746

CREATE – We can write compliant technical documentation, such as Technical Files, Clinical Evaluation Reports and Core Procedures

IMPROVE – We can update your technical documentation to meet the changing regulatory landscape (such as MDR or UKCA)

Quality Management Systems

Standards: ISO 13485, GxP

We build bespoke Quality Management Systems or we can improve your existing system, to protect your market position.

UKRP service for devices

Giving you a legal presence in the UK (UK MDR 2002)

We also provide other named person services to the industry (RP, RPI, QPPV, QP)

Audits

Independent self-inspection, vendor qualification, critical service providers

Let us protect your position. We use a team of Jenson ‘in-house’ qualified and experienced lead auditors covering the following scopes (ISO 13485, ISO 9001, GMP, GDP, GCP, GVP, GLP).

Don’t get caught out!  We can prepare you for EU Notified Body, UK Approved Body and Authority audits. We make sure you’re compliant.

Post Market

Medical Information & Scientific Services

Our experienced vigilance and medical information teams are here to support your business needs.

We can provide a medical/scientific information service with dedicated lines, Literature searches, Field reporting (FSN, FSCA), PMCF & PMS (Plans and Reports). Data reconciliation, metrics and trend analysis.

Borderline Analysis

Regulatory triage and trouble shooting

We have a wide range of technical regulatory experts. We can ensure that you have followed the correct regulatory pathway and make recommendations to protect your strategy.

Risk Management

ISO 14971

We can assess you approach to Risk Management and support your approach for medical device lifecycle risk management.

Copy Approval / Clinical Evidence

Branding & promotional claims

We can review, co-ordinate, and even write your materials for advertising, training and promotion.

We want to make sure that you are legal and have evidence to support your branding and claims. Don’t give your competitors any ammunition to take to the regulators.

Training

Bespoke or ‘off the shelf’, remote or at your site

We write and present bespoke training courses and the medical devices sector is no different.

We can provide a short or a detailed programme which will focus on the regulatory detail necessary to equip you and your team. We want you to take on your tasks from a position of knowledge.

Supporting Authority Interface

Professional regulatory opinion and sector justifications

We support clients who are facing authority restrictions and we write regulatory justification where there is a difference of (Client/Authority) opinion.

Jenson also offers many other device lifecycle services so you can be reassured, you really are in good hands.

Come and talk to us for an open and informative discussion, without obligation.

James Hall
Director

We would like to talk to you and we will listen.

We aim to understand your objectives, your aspirations and your ultimate goals.

CONTACT US