Your experts on MedTech regulation and compliance

Devices and Diagnostics

Your experts on MedTech regulation and compliance

The MedTech landscape is evolving rapidly, as new and emerging technologies — with their accompanying new and emerging legislation — are constantly being developed. Innovation, regulation, and advancements in science are creating an ever-increasing intensity of competition.

Whether developing a medical device, drug delivery device, or In Vitro Diagnostic (IVD), the industry is being driven to deliver better, faster treatment and diagnosis for patients, as well as less invasive approaches and reduced recovery times.

Our team of expert consultants in medical device and diagnostic regulation can support you in navigating this complex environment — guiding you through processes and enabling you to enter and succeed in global markets.

From device design to post-market surveillance, and all the stages in between, we can assist you to overcome regulatory compliance and quality challenges to deliver your product to patients and healthcare providers that can really benefit.

Covering the EU 2017/745 Medical Device Regulation (MDR) / EU 2017/746 In Vitro Diagnostic Regulation (IVDR), UK Medical Devices Regulations 2002 and the US FDA 21 CFR, among many others, we can support you in gaining certification from an appropriate notified/approved body.

Woodley BioReg has developed significant experience in ensuring medical, drug delivery, and IVD products gain certification through robust regulatory and quality strategies, ensuring submissions are tailored to specific needs of the type and class of product.

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