Keep a pulse on the latest in medical device regulations

With the medical regulatory landscape having undergone it’s most significant overhaul in years; comes a need to stay up-to-date with the latest regulatory intelligence and how the changes impact your organisation.

This brochure brings together LRQA’s Best-in-class technical expertise about:

  • CE Marking certification against the existing Medical Devices Directive 93/42/EEC (MDD) and In Vitro.
  • Diagnostic Devices Directive
  • 98/79/EC (IVDD)
  • MDR and IVDR Assessment and Training Services
  • ISO 13485:2016 Assessment and Training Services
  • Medical Device Single Audit Program (MDSAP)

LRQA has been a leading Notified Body for over 20 years, and is independently accredited by the relevant accreditation bodies to provide CE marking to MDD 93/42/EEC and IVDD 98/79/EC.

We are recognised by almost 50 accreditation bodies and deliver our services to clients in more than 120 countries. We are also accredited by United Kingdom Accreditation Service (UKAS) and Standards Council of Canada (SCC) to provide ISO 13485 certification, and by SCC and Health Canada to provide CMDCAS certification.

Download the full brochure