Devices and Diagnostics



Giving you the best chance of success at certification

You’ve developed your device and carried out the necessary clinical evaluation and now it’s crunch time — submitting your product for regulatory approval. This stage can seem intimidating, and dealing with a Notified Body can be complicated and overwhelming.

At Woodley BioReg, our team of experienced and knowledgeable ex-agency and ex-industry regulatory consultants that specialise in MedTech can guide you through the certification process to ensure a successful outcome when submitting your product for approval.

Paperwork submissions

Submitting your documents — design dossier, Technical File, CER / PER file, renewal applications etc. — requires a high level of attention to detail and scrutiny. Applications are not likely to be successful if any details are missing, incomplete, incorrect, difficult to locate or improperly formed.

Our qualified consultants are highly experienced in collating all information and submitting your application to the Notified Body, assisting you with the submission and technical document contents, submission method, document format, and the submission process.

Question responses

Following your application, the Notified Body may have questions regarding your product or data. Woodley BioReg’s consultants are well-practised in responding to these queries with the regulatory strategy in mind — helping you through a smooth certification process and ultimately, device approval.

Our aim is to make the certification and Notified Body review process as efficient as possible, supporting provision of the necessary information to the regulatory agency to ensure the best possible outcome for your device. By utilising the services of Woodley BioReg, our specialists will advise and guide you throughout the entire process.

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