Welcome to AlfaNordic A/S - Excellence in GMP

Medical Device

Up-to-date with the latest trends

AlfaNordic’s Medical Device Consultants

The challenges within legislature and development via manufacture, sales, distribution and marketing are dynamic processes to be followed closely to keep your products up-to-date. AlfaNordic can assist you with expert knowledge and guidance of a high quality through all phases of the medicinal product’s life cycle. Since 2009, the regulatory authorities have directed a tightened focus on companies making use of medicinal equipment, particularly with regard to CAPAs, Design Controls, Complaint files, PPQs and procurement. This development is due to increased regulation and more stringent quality requirements. Lately, the industry has experienced an update to Eudralex, a new PPQ methodology, a generally more risk-based approach and philosophy and a new version of ISO13485.

We can help with efficient systems

Challenges like these require that companies stay at the cutting edge and continuously improve their internal systems and processes in a more progressive and flexible way. In order to improve the systems effectively it is necessary to use management systems, monitor product quality and ensure compliance with legislation in the everyday activities.

  • 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

  • QP – Qualified Person(s)

  • Sterilization 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

  • Process Validation (IQ, OQ, PQ)

Wide range of expertise

spanning our areas 

At AlfaNordic we make a point of being up-to-date with the latest trends within the medicinal equipment industry and training our experienced consultants in these areas. We at AlfaNordic are thus able to help companies stay at the cutting edge of future challenges and thus putting them in a position to react in a timely manner and to reduce time consumption and costs.

The ability to combine our expertise across our teams in both the pharma and the medical device industry is one of the strengths characterising AlfaNordic.

Why us?

We are a professionally specialised consulting department providing consultancy services and performing assignments for the medicinal product and the GMP governed industry. Because of our work within both segments we have a wide understanding of the problems within the two areas, but we also have knowledge of the differences existing in the individual industries.

  • We are trained lead auditors in ISO 13485, as audits play a big part of the daily operation. We perform internal and external audits and we counsel our customers with regard to preparation for third-party audits.
  • We conduct courses and train our customers’ employees. We can thus ensure that knowledge is increased and grounded in the company.
  • We provide consulting services concerning CE marking and we can act as external QA for your company if you don’t need a full-time QA resource.

The correct interpretation of the current regulatory requirements is the key for our customers to an efficient and successful production system. This is why we offer a wide spread of competencies that match the requirements dictated by the industry.

Client Advantage

Our employees all possess significant knowledge and experience within the medico-technical and pharmaceutical industry – both from the part of the customer and as consultants. Our consultants are all able to enter into a close cooperation with our customers as if they were part of the team in the company. This is true regardless of whether the assignment is for a short or longer period of time and whether it is in Denmark or abroad. As a consulting house we take an active part in spotting new trends in the industry and thus breaking down barriers and developing and creating sustainable solutions for our customers.

Our Track Record

Our consultants have performed projects for some of the biggest companies in Denmark and are therefore well equipped with regard to meeting market demands. But the size of the customer is not in itself a target, we also gladly provide services to smaller companies. Our projects within the consulting field have brought us to Asia, South and North America and to several countries in Europe. Customers like DAKO, Biogen, Novo Nordisk and Mediq are just some of the companies that our consultants visit. We hope that we can also pay you a visit.

Our sales and services process

The course of events for assignments normally goes through the following process.

1. Competency needs

The competency needs for the specified task are identified together with the customer. A sales meeting may be held. Please contact AlfaNordic sales department or an area manager.

2. Proposal and review

AlfaNordic draws up a proposal, identifies time frames and provides CVs for the task. The proposal is forwarded to the customer, followed by a review and a discussion. A meeting may be scheduled for further discussions of the proposal.

3. Contract

AlfaNordic sends the contract to the customer for approval. The contract covers economy, named consultants and time consumption, as well as start and end dates.

4. Start of task

AlfaNordic’s consultants start working on the task at the agreed date and time.

5. Continuous follow-up

AlfaNordic follows up on the consultants and continuously hold status meetings with the customer as well as with the consultants.

6. Completion of task and customer evaluation

The task is completed within the agreed time and economy. AlfaNordic follows up with a customer evaluation form and a concluding dialogue with the customer.

Our customer evaluations

from previous tasks

Average customer evaluations for completed tasks. Grades applied according to a scale of 1 to 5:

  1. Unacceptable
  2. Less acceptable
  3. Acceptable
  4. Good
  5. Very good
GMP training in 2015
Projects in 2015
Risk Assessment in 2014

Contact our

Medical Device Team

Do you want to know more. Do you have competency inquiry or request. Or maybe you want to present us with a challenge? You are always welcome to contact one our area managers. They are ready to answer your questions.

Charlotte Borgensgaard
Medical Device

T: +45 3144 7541