medical devices

medical devices

Medical devices industry

At bqs. medical devices and in vitro diagnostic medical devices sector has one of the highest priority. Our experienced team of doctors, technical and assessment experts is ready to provide professional service during the whole life cycle of your product and operating globally.

New regulations and standards are developing continuously in order to assure safety over medical devices producing around the world. regulation of medical devices and in vitro medical devices market will never be less strict than today. Choose bqs., assessment and auditing process and prove us, regulators and your customers your products, certified by bqs. are safe for our daily use.

  • ISO 13485
  • ISO 14971
  • ISO 15378
  • ISO 11137
  • 93/42/EEC
  • 98/79/EC

Do you have valid certificate?

Transfer it to bqs. and continue with current schedule

The trust. We make


Get bqs. certification and prove your commitment for safer and trusted world. By bqs. certification marks your customers are sure about what you do, safety of your product and its performance as you claim. bqs. regularly assesses, audits and tests your system or product and by our impartial and third party service, bqs. results are and always will be the most trusted.

ISO 13485:2016

Accredited quality management system certification according to ISO 13485:2016 standard by bqs.  is a right direction to satisfy your customers and regulators.


EC certification according to the European parliament and council directive 98/79/EC covering In vitro diagnostic medical devices


EC certification according to the European parliament and council directive 93/42/EEC covering medical devices

Get in touch and inform about your industry certification solution

bqs. certification solutions enhancing the trust into your business