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Tips available! How to prepare to the new European Medical Device Regulations (MDR)?

Finding answers? Welcome! - This is an unofficial guidance which is intended to assist medical device OEMs by sharing some tips on how to prepare to the new European Medical Device Regulations,...

Conformity assessment and CE marking – get your new Medical Device to the market under new European Medical Device Regulation

In our previous MDR related blog post we discussed on how to ensure that your existing products are compliant with the new medical device regulation. Now we’re sharing some tips on how to get ready...

Conformity assessment and CE marking - are you ready for the new MDR with your existing products?

In our previous MDR related blog post we discussed how to proceed in implementing the new MDR to your Quality Management System. The QMS requirements are assessed for all existing certifications from...

Prepare your QMS to the new MDR – tips available!

The new Medical Device Regulations (2017/745/EU) (MDR) will replace the existing Medical Devices Directive (93/42/EEC) (MDD) and the Active Implantable Medical Devices Directive (90/385/EEC) (AIMDD)....

Ready or not - the new European Medical Device Regulations (MDR) are coming!

The new Medical Device Regulations (2017/745/EU) (MDR), published in May 2017, will replace the existing Medical Devices Directive (93/42/EEC) (MDD) and the Active Implantable Medical Devices...

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