Gap Analysis to determine if you are audit-ready

You will benefit from an independent gap analysis of your current end to end processes and procedures, as it will provide you with opportunities to improve your processes, take action, and drive performance.

This also provides you with the opportunity to plan resources and allocate your time effectively, ensuring that you get it right the first time. This will give your stakeholders confidence in your organisation’s preparedness to meet the standard and obtain certification.

The gap analysis will be compared to the standards and regulations you aim to meet. This will help your organisation identify any potential oversights or weaknesses so that you can take the necessary action. It also provides a good introduction to more formal auditing and gives your team the opportunity to understand what a certification audit will involve.

How will the Gap Analysis work?

• The gap analysis can be conducted either remotely or on-site. However, remote audits can provide greater flexibility, especially if you want to move quickly.
• We will assess your processes and information to pinpoint any potential gaps in meeting the requirements of your selected standard.
• You will receive a comprehensive written report outlining observations and findings, identifying necessary steps, and we can help you remediate any issues as part of your audit readiness.

Review of your Medical Device Technical Files

Is your technical file structure easy to follow and is it presented in a clear, organised, readily searchable manner?

Annex II & III under the MDR 2017/745 and IVDR 2017/746 both stipulate that the technical documentation should be organised and concise.

We have worked with numerous different companies, and we regularly experience technical files that have not been set out in the most logical manner. It is always best to get a second opinion, as a layout that works for you does not always work for everyone else, including the reviewer.

Having a well-presented and descriptive technical file will help speed up the audit review process and reduce unnecessary questions from the Notified Body.

Are your technical files up to date? As a medical device manufacturer, it is key to ensure that your technical documentation is updated when you make changes and that you keep the contents of your file updated, e.g., systematic updates to clinical evaluation and risk management files.

Selling products on the EU/UK market requires keeping your technical files up to date in real-time for each device throughout its lifecycle. You can ensure this by having a well-defined change control process in place that considers changes that could impact your technical documentation.

Clinical Performance and Evaluation Documentation

We often come across clinical and performance evaluation documentation issues presented in the technical file.

It is important to ensure that your clinical and performance evaluation documentation is prepared in accordance with the respective regulations and available guidance. Your internal procedures should also align with regulatory requirements and current business practices to streamline the creation of evaluation documentation.

The same principles apply for the UK MDR 2002.

ISO 14971 Risk Management Activities

This standard is used for the application of risk management to medical devices, but companies consistently struggle to comply with risk management requirements.

If you do not keep up with the latest standard for risk management activities, you will be considered non-compliant.

If after your device is transferred to production, it is crucial that the risk management file is regularly reviewed or updated. ISO 14971 clearly outlines the requirements for the lifecycle process of any marketed device, including production and post-production information.

It is important to have a well-defined procedure in place, along with appropriate training where necessary, to facilitate the process and any additional required activities.

Non-Compliance with Post-Market Surveillance Requirements

Failure to comply with the EU MDR PSUR requirements could result in penalties, such as a product recall or suspension of marketing authorisation.

Regardless of your medical device’s status and how long it has been on the market, the obligations set out under Annex III of the MDR and IVDR clearly define manufacturer responsibilities.

Technical documentation is a live document that is required to meet regulatory requirements not only during development but must also be kept up to date throughout the life of your medical device.