Medical device – Compliance

The requirements to compliance in the whole Medical Device industry are currently elevating. This in order to secure patient safety and to secure appropriate availability on Medical Devices. The patients must be secured in every manner.

Due to this the patient safety will be raised through these tightened requirements that covers entrance of new products to the market as well as surveillance of already existing products that are on the market.

The AL Engineering Medical Device area therefore covers consultancy, sparring and assistance to the following compliance related tasks

  • Compliance with ISO 13485:2016 (valid 28 February 2019)
  • Compliance with of IVDMDR 2017/746 (valid May 2020)
  • Compliance with of MDR 2017/745 (valid May 2020)
  • Compliance with 21 CFR part 820
  • IT & automation, GAMP5
  • Validation of cleanrooms and related facilities
  • Analysis ISO 14971
  • Sterilization of medical device according to ISO 11137 of ISO 11135
  • Validation/qualification
  • Commissioning

Until February 2019 and May 2020, the Medical Device industry will be regulated by (within the EU):

  • ISO 13485:2003
  • EN 46001/2
  • EU directive 98/79/EC
  • EU directive 93/42/EEC
  • EU directive 90/385/EEC

Contact

Please contact Tina Linders for a non-committal talk about how we can make a difference for your company.

+45 2913 2445