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

Our Hybrid Audit programme has been developed using immersive technology to combine on-site visits with remote audits to create an agile, more sustainable way of working with our clients.

Hybrid audits have become increasingly popular among our clients, thanks to their ability to provide a more flexible and streamlined approach to audit delivery, as well as helping us all to go greener and reduce our CO2 emissions globally.

 

MDR QMS deadline 2023

Time for your MDR application is now

According to Amending Regulation (EU) 2023/607, if you are transitioning to the MDR, you will be able to benefit from extended validity of your directive certificates for legacy devices if some conditions are met.

Among these, by 26 May 2024 you have to put in place an MDR compliant QMS and lodge a formal application with a Notified Body for MDR Conformity Assessment.

Apply now
Download the transition guidance

Why go Hybrid?

  • Reduces your carbon footprint
  • Minimises unexpected disruptions
  • Allows for a more flexible and agile delivery of services
  • Access to an extensive global pool of auditors

How do Hybrid Audits work?

By using integrated technology, we have combined our traditional in-person visits, with cutting-edge remote audits to optimise and deliver the very best solutions that align with our clients’ new ways of working.

Our expert team will carry out a thorough risk analysis to check that your business meets the technical criteria to run this programme, which will be discussed with you by your scheme manager at the planning stage.

Cutting your CO2 Emissions with Hybrid Audits

Here at BSI, we are committed to advancing all of the UN Sustainable Development Goals; making a positive impact both through our own actions, and by helping clients to make sustainable choices.

We have pledged to reach Net Zero by 2030, which means we are constantly looking for new, innovative ways to deliver our services in a more sustainable way, whilst still performing at the standard our clients are accustomed to and meeting regulatory requirements.

By opting for a Hybrid Audit you are helping to cut carbon emissions.