Date of Application for the Medical Device Regulation

Today, May 26, 2021, is the Date of Application for the Medical Device Regulation (MDR 2017/745), one year later than initially planned.

Over the past years, focus has been on the new regulatory requirements for all economic operators, and the pieces are finally starting to come together.

For manufacturers, developing the technical documentation and implementing Article 10 requirements in the quality management system, as well as ensuring sufficient clinical evidence for all medical devices, is mandatory to be able to continue to keep them on the market as CE-marked according to MDR.

Irrespective of existing certificates and softer transition for certain product classes, a system for post market surveillance and vigilance must be in place by today for all manufacturers.

Next to come – The corresponding date of application of the In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746) on May 26, 2022.

MDR process

Technical documentation for CE marking

 

Very welcome Frederik Roos!

We are very happy that Frederik has joined our team. Fredrik will hands-on support our clients to safely and effectively navigate through the product development aspects in a regulated environment.
He has 12 years of experience from the medical device industry with many leadership roles within international product development. Frederik holds a M.Sc. in Chemistry and a B.Sc. in Chemical Engineering.

 

Mikael Karlsson has joined QAdvis!

We are very pleased to welcome our new colleague joining our QA&RA consultant team. Mikael has a master’s degree and over 20 years of experience in product development and production from innovative companies within Life Science and Space Technology. Over the last 12 years he has been focusing on Quality Assurance and Regulatory Affairs management applied to medical devices and IVD devices. His broad industrial background and natural focus to always find efficient but compliant hands-on solutions to small/medium size companies’ quality and regulatory challenges is highly appreciated.

Read more about our services in Medical Devices – Development.

 

We are pleased to share some great news about the further strengthening of our Quality and Regulatory team.

We welcome Krishnadev Moothandassery Ramdevan who has just started as QA&RA consultant, based in our office in Stockholm. He will be a great addition to our team.

Krishnadev has his master’s degrees in Medical Engineering from KTH, Stockholm.  He has a background in software development and testing for pharmaceutical and life science companies, with an experience of around 7 years. During the past few years, he has focused on quality and regulatory work for medical device companies, helping them build their own QMS and aiding their software development process to be complaint with MDR, or according to relevant standards such as IEC 62304, ISO 13485, and ISO 14971. He is looking forward to further dive into the world of QA/RA along with the rest of the team

Read more about our services in Medical Devices – Development.