Hybrid audits for medical devices

Hybrid audits for medical devices

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Hybrid Audits for Medical Devices
Hybrid Audits for Medical Devices
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The new way of working post-pandemic

The COVID-19 pandemic has forced the medical device and IVD sector to consider new and innovative ways of meeting regulatory demands while keeping patient safety at the forefront of our role. As a sector, we have risen to the challenge of COVID-19 with professionalism and resilience, and we have found new ways of ensuring we meet our responsibilities.

Despite its severity, the pandemic has also managed to inspire some positive changes.  For example, Auditing Associations have increased the use of immersive technologies to conduct remote audits. This experience has provided solid learnings and evidence around the use of the new technology.

First and foremost, Hybrid audits and risk assessments have helped to keep our audits going during various stages of lockdown, leading to a continuation of supply for healthcare providers and ultimately patients. And the majority of our clients have been able to maintain their audit cycle. They recognize how critical having practices and processes in place has been to retaining resilience during the pandemic. In addition, the use of technology has reduced the risks of outbreaks at our client's site and has protected our colleagues during this uncertain time.

What is a hybrid audit for BSI Medical Devices?

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.

Moving beyond the pandemic

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 our experts without geographical constraints

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 Sustainability commitment

UNSDG imageBSI 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.

Benefits of hybrid audits

  • Maintain your audit, training and inspections schedule.
  • Align with the technology that works best for you with our flexible approach to hybrid audits.
  • Significantly reduce the carbon footprint by implementing less travel for our auditors.
  • There is a significant investment in additional hardware, software, infrastructure and licensing required. We aim to provide hybrid audits on a cost-neutral basis to manufacturers utilizing savings in travel.
  • Access to BSI experts without geographical constraints.
  • Be consistent with communication between your participants and the BSI expert through a single live stream.
  • Flexibility for manufacturers.
  • Improved work-life balance for our audit teams, with reduced travel time, and the Resourcing process will be more effective with the ultimate improvement in better client service levels.
  • Equally effective comprehensive audits (HBS and Internal Data).

Our technologies

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

online video chat with headset

Level 1: Live web streaming 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

Secure sharing platforms may also be used to transfer documentation.

live streaming paired with mobile technology

Level 2: Live streaming paired with mobile technology

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.

smartglass technology

Level 3: Live streaming paired with smartglass technology

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.

drone technology

Level 4: Drone and satellite aerial imaging and analytics

As part of our Immersive Technology Solutions, we are currently using drones, unmanned aerial vehicles (UAVs) or satellite imagery to bring our clients a safe, cost effective experience that brings superior levels of analytics, planning and lifetime digital remediation of corrective issues.

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