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.
The technical documentation for your device is the entirety of the documents that describe it. It’s the manufacturer’s responsibility to prepare the Technical File for any classification of device. The documentation should be controlled by the Quality Management System (QMS), and regularly updated to ensure ongoing compliance during the product’s lifetime.
The Technical File is a comprehensive document that requires significant attention to detail, and can therefore be heavily resource consuming. At Woodley BioReg, our consultants can support and guide you through documentation preparation, review your own Technical File, or create the file on your behalf.
With decades of experience spanning all classes of products and devices, our specialist MedTech team is adept at creating Technical Files that “tick every box” – so you can be confident that all vital information has been included in line with your regulatory strategy when it comes to the submission stage.
Data gathering at the preclinical development stage may be required and therefore it’s important that the development of the preclinical programme is aligned with the regulatory strategy.
At Woodley BioReg, we can support and guide you through the process of developing the preclinical programme to ensure that you get the data that you need to progress.
We’re not just experts in regulatory affairs, but our team of quality consultants can help you to develop a Quality Management System (QMS) relevant to your product — most likely ISO 13485 and ISO 14971 — to ensure that the processes in place to manufacture your device are controlled and documented to ensure compliance.
We can ensure that your QMS is fit-for-purpose and up to standard for audits — both internally and by visiting authorities — with our team of specialist quality consultants on hand every step of the way.
The process of risk management involves the application of management policies and procedures to the activity of analysing, evaluating, and controlling risk — and in relation to medical and In Vitro Diagnostic (IVD) devices it also has a great relevance to the risk class of your device. Therefore, it’s critical that it is done correctly.
We can work with you to develop and implement your risk management plan, identifying, controlling, and mitigating risk as much as possible to ensure both safety and efficacy for your patients, and ease of registration for your product.
For most classes of medical devices (apart from MDR/IVDR Class I) you will be subject to annual audits by the relevant Notified Body to ensure ongoing compliance. If for any reason you fail this audit, your certificate may be suspended or withdrawn. Internal audits also should be regularly carried out in line with your QMS to ensure the right controls are in place and continue to be effective.
At Woodley BioReg, we’re experts in auditing (and proving workable remediation plans aligned to your business). We can help you to plan for your annual external audits, so you can be sure you’ve done everything to prepare. Our consultants can also support you with internal auditing, either by guiding you through the process or carrying out the audit in full on your behalf.
