Devices and Diagnostics

Certification

Introduction

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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360 Value

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Clinical Development

The main activities in the clinical development phase of a medical device is the undertaking of clinical assessments, i.e. clinical trials. The data and information gathered from these studies are used to demonstrate and evidence the safety and efficacy of the device’s use in a human healthcare setting — ensuring that they are as safe as possible before they are placed on the market.

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Technical and product development

Once you have progressed past the initial design stage, navigating the intricate regulatory and quality development stage can seem daunting. Our specialists are available to support and guide you from start to finish, with specialist knowledge and decades of experience in MedTech regulatory affairs – you can be sure you’re in safe and diligent hands.

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Regulatory strategy services

For the highest chance of success, a defined, comprehensive regulatory strategy that takes into account both commercial and scientific considerations is vital. Our team of experts will support you in traversing the correct regulatory pathway, allowing you to take the most appropriate route to market while remaining compliant.

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Post-market activities

The ever-evolving regulatory landscape increasingly emphasises the responsibility for manufacturers to demonstrate proactive monitoring of their products after they have been placed on the market. It’s therefore vital that device manufacturers have thorough post-market surveillance systems in place to collect vigilance data, supporting the continued safety and efficacy of the product, as well as minimising any risks to end-users.

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Supplementary Services

We offer a range of supplementary services to ensure that we offer the highest quality support to our clients. Our consultants are on hand to offer guidance and advice every step of the way — giving your product the best chance of success in achieving and maintaining compliance.