MEDICAL DEVICES

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.

IMPLEMENTATION OF MDR

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.

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WE CAN HELP WITH EFFICIENT SYSTEMS

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.

OUR EXPERTISE WITHIN MEDICAL DEVICE

The following are examples of our expertise within Medial Device

MDD / MDR

European medical device legislation is changing. We have extensive experience with MDD, are fully updated on MDR and understand the differences from MDD and MDR. The MDR system is yet so new and is without precedent from implementations and audits. Our long MDD experience enables us to assess the implementation of MDR.

FDA 21 CFR PART 820 ETC.

US medical device legislation can seem daunting and a barrier to export to the world's largest medical device market. We have the experience to extend the quality system to include US requirements, assist in inspections and help companies leverage "Warning Letters" after a failed inspection. However, MDSAP and the latest version of ISO 13485 have made the FDA less daunting.

ISO 13485

Quality management for Medical Device Quality management of medical devices underlies not only European legislation MDD and MDR but also MDSAP (Medical Device Single Audit Program). ISO 13485 specifies the requirements for what a quality system should contain. We have extensive experience in designing and optimizing quality systems.

UNIQUE DEVICE IDENTIFICATION (UDI)

UDI is a new requirement for all medical products according to MDR. Later, EUDAMED must be implemented. We can review the product portfolio and update it with UDI. Once EUDAMED is implemented, we can specify the interface for your ERP system so that data can be transferred.

USABILITY ENGINEERING, EN 62366

When developing medical devices, care must be taken that the user does not operate the equipment incorrectly or directly abuse it. We can facilitate workshops and provide the required documentation for Usability Engineering File.

CE MARK

To place a CE mark on a medical device, it must be documented that it is safe and effective. All relevant evidence must be collected and displayed if the authorities so wish. What are the requirements, what is relevant and how is the documentation designed? We have regulatory experts who can support or prepare the technical file.

LET US REACH THE GOALS TOGETHER

Let's talk about your company and the possibilities for a possible Cooperation.

CONTACT US ABOUT MEDICAL DEVICE

Get the message out, with the assistance of AlfaNordic

Jesper-Madsen-Wagner-AlfaNordic

Jesper Madsen Wagner

Team Manager, Medical Device 

Subject areas
Medical Device
Quality management and consulting
Customer contact

+45 31 44 75 18
jew@alfanordic.com

Lisbeth Bonde

Business Developer  

Subject areas
Customer contact
Offers and contracts
Follow-ups

+45 31 44 75 44
LIBO@alfanordic.com

LET'S GET STARTED

BOOK A CONSULTATION, FREE OF CHARGE 

Are you ready for changes? Let us talk about your company’s ambitions and how we can break through in a new country.

Get an idea of what we can offer, by participating in our inspiration meetings. Here our specialists share their knowledge and experiences.

MEET OUR SPECIALISTS - PARTICIPATE IN OUR INSPIRATIONAL MEETINGS

CONTACT US

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.

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