In line with the changing world, BSI has reimagined the way we audit Medical Device Manufacturers

BSI is enthusiastic about the use of hybrid medical device audits. Part of the audit offering remains in-person and onsite, but a significant proportion is now delivered remotely.

The formal definition of BSI medical device hybrid audit:

An audit is partially performed off-site using ICT while at least one auditor qualified under the certification scheme is onsite during a portion of the audit. The audit will be delivered simultaneously with a proportion delivered in person onsite.

As an EU notified body and a UK approved body, we must work with our Authorities in both the NL (IGJ) and the UK (MHRA) to ensure our actions are effective, efficient and legal. The mandatory requirement for onsite audits remains a critical part of the regulatory requirements in the EU and UK. As such, we must return to in-person auditing to ensure your products maintain market access.

Hybrid audits can improve work-life balance for our auditors. Our experts' reduction in travel times means they can use their time to support your audits rather than spend their lives on the road. Increasing the use of hybrid audits can create a better balance for both the auditor and auditee, as the time we spend on your audits adds value. We believe that the resourcing process will be more effective, ultimately improving better client service levels.

Hybrid audits can also improve the sustainability of assessments, both environmentally and from the perspective of wellbeing. Also linked to a reduction in travel is a reduction in greenhouse gas emissions. In 2019, BSI conducted thousands of onsite audits. In smaller countries, our auditors typically travel by car. However, air travel is necessary for larger countries like America, Australia, Canada and China.

While fully remote audits will not be recognized for the majority of audits from a regulatory perspective after the pandemic, they are a good option for sites where access isn't possible or travel restrictions are in place. The process of a remote audit can have its challenges. The body language cues each side can pick up from the other often helps facilitate an onsite audit experience. The sound and connectivity levels in some manufacturing facilities also interfere with the inspection of production or storage areas, which is why the use of hybrid audits will be proposed going forward, the best of both worlds.

Access to our Technical Experts is scheduled based on the technology of the medical device submitted and the right qualifications for the reviewer; please refer to MDCG guidance on MDR Codes and IVDR codes. The use of specialist reviewers ensures patient safety remains our focus. This means that the person looking at your product specializes in the technology and can understand your submission.

The technical qualifications of our auditors can sometimes lead to scheduling challenges due to the geographical location of people with the specific expertise you require. Using a hybrid process will allow our highly qualified experts to support you no matter the geography, giving you direct access to the right person. In addition, remote scheduling should make our resources plans more efficient and improve your service.

BSI was established in 1901 with 'responsibility to society' as one of its main objectives, and this has never been more relevant than it is today.  We are a signatory of the UN Global Compact, the world's largest sustainability network, and are proud to support its principles, as well as the UN Sustainable Development Goals.

We are committed to advancing all the UN Sustainable Development Goals, making a positive impact both through our own actions and helping clients make sustainable choices.

The goals we believe we are best positioned to advance at BSI are listed here. Those in bold will be impacted by our use of hybrid audits in the future:

• Goal 3: Good health and wellbeing
• Goal 7: Affordable and clean energy
• Goal 8: Decent work and economic growth
• Goal 9: Industry innovation and infrastructure
• Goal 11: Sustainable cities and communities
• Goal 12: Responsible consumption and production
• Goal 17: Partnerships for the goals

Our efforts focus on advancing these goals, in particular, recognizing that all the goals are interconnected. Discover more about BSI efforts for UN SDG's.

BSI is looking at various immersive technologies; for Medical devices, we are currently using Level 1 and 2 technology.

Live streaming technology such as MS Teams, Webex and Adobe Connect to support:

• Document, record and procedure review
• Live interviews with your teams
• Connected learning live - our online training service

Transfer documentation securely on sharing platforms.

Video applications on smart devices (phones and tablets) immerse our teams.

This technology enables virtual site tours. It allows us to observe the implementation of processes and activities in real-time.

Fully immerse in the audit by using hands-free technology such as smart­glasses and video headsets.

We provide immersive technology equipment in advance of the audit for your teams to use in action.

Live feeds communicate data to our augmented reality platform for verification by our experts.

As part of our Immersive Technology Solutions, we use drones, unmanned aerial vehicles (UAVs) or satellite imagery. These bring our clients a safe, cost-effective experience with superior levels of analytics, planning and lifetime digital remediation of corrective issues.