Updated with the latest legislation
At AlfaNordic, we make a great effort to keep abreast of the latest trends and legislation in medical devices and constantly keep our experienced consultants up to date. Therefore, we can help companies stay on top of upcoming challenges, enabling businesses to respond in a timely manner, saving time and costs. The ability to combine our expertise across our teams in both the pharmaceutical industry and the Medical Device industry is one of the strengths that characterize AlfaNordic.
Medical Device Regulation (MDR), 2017/745 comes into force 26 May 2021. The new legislation will change the life of every actors who are part of the supply chain of medical devices The new legislation will change the life of every actors who are part of the supply chain of medical devices.udstyr træder i kraft. Den nye lovgivning har forandret hverdagen for alle aktører, som er en del af forsyningskæden af medicinsk udstyr.
AlfaNordic can review the quality system and product portfolio and provide a way to meet the new requirements. We can also help with the work or the project management.
Compliance with the legislation is “License to operate”, but the quality system must support the business - It must not be an obstacle to act.
AlfaNordic's consultants have a business understanding and not only implement processes that meet the legal requirements, but also based on how your unique business works in everyday life.
The following are examples of our expertise within Medial Device
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Get an idea of what we can offer, by participating in our inspiration meetings. Here our specialists share their knowledge and experiences.
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Do you have any questions, or do you want to know more? Contact us. You can find our contact information below. We look forward to hearing from you.