Compliance & Quality Assurance Pushed to the Forefront
Newly hired Quality & Compliance Manager to focus intensely on quality assurance and compliance with The Medical Device Directive.
22. August 2018
At Vendlet, it has always been a high priority that our products meets the demands of The Medical Device Directive. However, as the company grows, and our product assortment expands, we also expect more of ourselves. Therefore, we are expanding the team with a new Quality Department, which will be lead under the careful supervision of our new Quality & Compliance Manager Annika Matzen. Annika has worked with quality assurance for 12 years and will oversee all documentation regarding The European Medical Device Directive and Vendlet’s quality assurance systems.
Newly Established Quality Department to crack down on The Medical Device Directive
Annika will be the first employee in Vendlet’s new Quality Department. She has a great deal of experience with documentation and compliance with The Medical Device Directive and has also previously worked as a quality engineer at NNE Pharmaplan. Furthermore, Annika has a master’s degree in Food Science from the Royal Veterinary and Agricultural University in Copenhagen and has now chosen to seek new opportunities at Vendlet.
“I look forward to being a part of a company, where my area of expertise is highly prioritized. It is a very exciting area, which is under continuous development, and it isn’t going to get any easier in the future,” she says, and continues: “It is very clear to me, that compliance has been highly prioritized for many years at Vendlet, and that it isn’t just considered a necessary evil. This is one of the major reasons why I have chosen to undertake this position and the challenges of further developing this area.”
Medical Device Directive not to be Taken Lightly
The Medical Device Directive, which applies to all equipment intended for diagnostic or therapeutic purposes on humans, prescribes a series of minimum requirements for these types of products and is enforced throughout the EU. Besides meeting the standards laid out by the directive, Vendlet as a company has always been dedicated to safety and knowledge-based decision making as the two core values of our products.
Therefore, it is a natural next step to expand the company with a dedicated department, which will be responsible for these matters: “Vendlet is a company that takes The Medical Device Directive very seriously. As a company in the medical device industry, we have long been wanting to get someone on the team to focus solely on this area. This is not least due to the ever increasing complexity in The Medical Device Directive. And with the increased internationalization Quality & Compliance is something which will take up more and more resources. Therefore, it has been a natural next step for us, as a company, to get Annika on the team,” CEO, Peter Maindal, states about the new expansion.
New Regulation Increases Requirements
Going forward, the requirement for clinical documentation will only continue to rise. The new regulation, which will be imposed in 2020, will bring a lot of new challenges. Among other things, the regulation will increase the requirements for documentation; something which is welcomed with open arms by Vendlet’s CEO, Peter Maindal, who generally encourages higher requirements for businesses in the medical device industry. In addition, the new regulation also entails that all businesses working with medical equipment must have resources dedicated to working with compliance and quality assurance. Naturally, this is where Annika will play an important part.
Annika has had her first day of work at Vendlet on the 20. August, and can be reached on
Tlf.: +45 6098 2170