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. 2017/745 Forordningen om medicinsk udstyr takes effect. The new legislation will change the everyday lives of all players who are part of the supply chain of medical devices.
Is your business ready for May 26, 2021? 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.
AlfaNordic's Medical Device consultants have expert knowledge in the regulatory field, but we also have experts in change management: We know how change is anchored so that the new requirements become part of the existing corporate culture.
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.
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.
The following are examples of our expertise within IT and Automation:
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.
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.
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.
Everything starts and ends with Risk! We can prepare Risk Management File but also facilitate RISK workshops (SW, design, Usability, process) so that risks are mitigated and the products become safer and better.
UDI is a requirement for all medical products in Europe per May 26, 2021. 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.
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.
Software as part of a medical device or as an independent medical device must be documented in relation to the risk class. We can help you along the way and develop the strategy for documenting your software development.
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.
ISO13485 requires periodic internal audits to be carried out to verify that the quality system is properly implemented. The auditors are required to be trained. We have trained auditors who can help you. We can also support you through external audits; both during and after if there are any questions that need to be answered.
Is change management saying the same thing 21 times? How about a burning platform? Both help, but more is needed. When the legislation is changed and the quality system is updated, the next audit result depends on the implementation. We have the experience of getting organizations to work in new ways.
“Design Controls” ensures that your R&D development processes are managed and along the way come up with the right documentation so that the product can be CE marked afterwards. It is important that the development process follows the legislation, but also that the legislation creates value in the development process. If the rules are understood correctly and implemented correctly in the value chain, they will create value.
GMP or Good Manufacturing Practices is a set of rules and a culture that must be present in the production area but also with the subcontractors. GMP ensures a good and uniform quality of the products on the market. Work culture is often one of the reasons GMP is difficult to implement as positive intentions can lead to misunderstandings.
MDR requires that a quality responsible person have both professional training and regulatory experience. If such a person is not present in the company, the role can be handled externally. We would like to make one available.
If the product from a process cannot be 100% tested, the process must be validated and the equipment qualified. The rules are simple but experience is important for making a good validation strategy and performing the qualifications and validations. We have experience in many types of manufacturing processes and a systematic approach to qualification and validation.
We are a specialized consulting department within AlfaNordic, serving the pharmaceutical and biotechnology industry. We feel able to compete with companies with much bigger size for the following reasons:
AlfaNordic follows up on the consultants and holds regular status meetings with both the client and the consultants.
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