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Quality &

 Regulatory 

Expertise

MEDICAL DEVICES & IVDs

About Us

PRQR delivers Quality, Regulatory and microbiological expertise for Medical Devices and IVDs across the UK and Europe. We specialise in bringing medical devices and IVDs to market and remediating issues raised by Notified Bodies and other regulatory authorities.

 

We work with all sizes of companies from the very smallest right through to large multinationals, and we are particularly geared to helping Small and Medium Enterprises (SMEs), start-ups and University spin out companies to navigate the regulatory maze and deal with the sometimes difficult but very necessary regulations in our industry.

 

PRQR is an authority is supporting small businesses and start-ups, providing targeted, high-quality consultancy whilst helping you to stay in control of your costs. Our mission is to break the mould of consulting companies. We are here to help you, to get you through whatever regulatory, quality or microbiological issue you are facing. We won't linger and invent additional work just to keep on charging you, that's not how we work. Equally, we won't abandon you once we've done our job. Further advice is only ever a click or a phone call away and we will check in on you from time to time, just enough so you know you are being looked after properly.

 

What We Do

Medical Devices

Regulatory

Medical Device Regulation

MDR 2017/745

Medical Device Directive

MDD 93/42/EEC

Active Implantable Medical Device Directive

AIMD 90/385/EEC

Quality Systems

EN ISO 13485:2016

21 CFR 820 - QSR

Auditing Services

Risk Management

EN ISO 14971:2019

Microbiology

Sterilisation Validation

Contamination Control Strategies

Cleanroom & Controlled Environment Room

IVDs 

Regulatory

In Vitro Diagnostic Medical Device Regulation

IVDR 2017/746

In Vitro Diagnostic Medical Device Directive

IVDD 98/79/EC

UKCA
Mark

All your UKCA Mark

Regulatory Requirements

Deadline to UKCA mark for the GB market is 30 June 2023

Small & Medium Business Specialists

The Medical Device Industry has a handful of large companies who dominate certain segments, however there are more people employed and more devices made by the SMEs in our industry. In fact there are tens of thousands of SMEs all innovating and bringing their devices to market for the benefit of patients.

Sometimes you just need a specialist, and PRQR Ltd brings over 27 years of regulatory and quality experience of countless different device types across all device classes. We are acutely aware of the issues SMEs face in getting products to markets and compliance in general. We care passionately about our industry and genuinely care about our clients success and helping patients with safe and effective products. We have special rates for SMEs and go out of our way to make sure you understand what we are doing so you always remain in control. 

Testimonials

I have known Pete for over 10 years. He is highly knowledgeable, an excellent communicator, dedicated to the industry and always puts his clients first. I am happy to recommend him

Costa Philippou, Medilink East Midlands

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