Medical Device

Updated with the latest legislation

AlfaNordic's Medical Device consultants

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.

Implementation of MDR

Is your business ready for May 26, 2021?
Take AlfaNordics advice

AlfaNordic can review the quality system and product portfolio and give you the answer. We also provide a way to meet the new MDR requirements.

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.

Compliance with ISO 13485 & ISO 14971
Internal & External Quality Audits
Risk Management (acknowledged tool package)
Unique Device Identification (UDI)
Handling of Complaint files
Combination products
PRRC – Person Responsible for Regulatory Compliance
Sterilisation of Medical Devices

Compliance with FDA 21 CFR Part 820 & MDD
Quality Assurance & Management
Change Management
Medical Device Regulation incl. CE Marking
Production and Process controls
R&D Documentation and maintenance
Qualification and Validation (IQ, OQ, PQ)

Wide expertise across our professional fields

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:

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.

ISO 13485

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.

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.

Risk Management, ISO 14971

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.

Unique Device Identification (UDI)

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.

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.

Software development, EN 62304CE

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.

CE Label

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.

Internal and external audits

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.

Change management

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 experience in getting organisations to work in new ways.

Development documentation and maintenance

“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.

Production and process control

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.

PRRC – Person Responsible for Regulatory Compliance

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.

Process Validation (IQ, OQ, PQ)

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.

Why us?

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:

We combine sound management consulting with in-depth pharmaceutical and biotechnology expertise, built up over many years of industry experience.
We hire talented people who are capable of keeping several balls in the air at the same time. Quality, swiftness and execution are key words to ensure an effective way of working, whether as a participant across teams or as a senior management consultant.
We promote professional and personal development and strive to make talented people even better.

Controlled growth and increasing efficiency are often the key to a company's success and profitability. These goals are just as often the company's main priorities, but can be reduced or disappear by daily disruptions of inadequate and risky processes in administration and production. As a partner, AlfaNordic will be the best within the field. We evaluate the strategic risk and provide organisational advice to the entire value chain of your company.

Our sales and delivery process

1. Competency needs

The competence requirement for the desired task is described together with the customer. Possibly a sales meeting will be held. Contact AlfaNordic Sales or a Function Manager.

2. Proposal and review

AlfaNordic prepares presentations, time requirements and CVs for the task, as well as sends the presentation to the customer and goes through it. A possible meeting for further discussion of the presentation.

3. Contract

AlfaNordic submits a contract for approval by the customer. The contract includes financial information, named consultants and time consumption, as well as start and end dates.

4. Start of task

AlfaNordic's consultants start the task at the agreed time.

5. Continuous follow-up

AlfaNordic follows up on the consultants and holds regular status meetings with both the client and the consultants.

6. Completion of task and customer evalution

The task ends at the agreed time and with the agreed price. AlfaNordic follows up with a customer evaluation form and a final dialogue with the customer.

Contact our Medical Device team

Ole Markersen

Director, Medical Device, Quality Assurance, Regulatory Affairs & Pharmacovigilance

+45 3144 7511

Rasmus Kriegel

Partner, Sales

+45 3144 7515