Medical Devices & IVDs

The tranScrip team works as an extension of your team – your trusted advisor in the ever-changing medical device regulatory landscape. Our specialists keep a constant eye on all the latest developments in the field – new and updated regulations and guidances, new research, and different approaches – and we’ll provide you with first-rate medical device regulatory support.

Our specialists look to fill any knowledge gaps you might have, and offer expert advice on any medical device you need to know about.

Whatever the case, we’re here to help.

We cover the determination of product classification, preparation, and submission of regulatory documentation – including technical files and design dossiers, registration for product applications and clinical investigation applications. We also write and update clinical evaluation reports (CERs), liaise with European competent authorities and notified bodies and UK approval bodies.

From a medical device perspective, the tranScrip team helps with:

• Implementation of EU Medical Device Regulation (EU 2017/745)
• Implementation of In Vitro Diagnostic Medical Devices Regulation (EU 2017/746)
• Implementation of UK Medical Device Regulation (UK MDR).
• Medical device qualification and classification
• Determination of Labelling Requirements
• Support with regulatory/medical device quality management system (QMS) gap analysis
  tranScrip can also act as your Person responsible for Regulatory Compliance (PRRC) as required under article 15 of the MDR.

With expertise in international regulations, we can also assist in gaining access to markets outside of Europe.

Beyond that, we oversee medical device vigilance and reporting systems and oversee all matters of risk management (ISO 14791).

Other areas we cover include regulatory and manufacturing compliance, strategic and regulatory planning, and auditing of quality and regulatory systems to ensure compliance with relevant medical device industry standards, in particular ISO 13485.