Client Case

QMS-implementation at Henro-Tek

Client and company:
Robert Frænell
Owner & Founder

Business goals and context for the company

The customer needed a quality management system to document their quality processes, and to be able to comply with the MDR requirement of having a QMS. By having an ISO13485 compliant QMS, the customer would be more attractive as a business partner and as a supplier.

Initial challenge for the company

The customer requested guidance at both strategic and operational levels. The company needed support in: interpret the MDR requirements, QMS processes and procedures, and advising on daily use of the system.

Medicologic solution and contribution

With offset in the Medicologic QMS, all the required quality system documents were identified and adjusted to fit the customer. This type of cooperation needs an in depth understanding of the customer-needs, and of the external requirements relevant for the particular business area.

Results

An ISO 13485 compliant QMS system ready for operations by the customer. With this the ability to seek new business possibilities by now being able to send the valuable signal of having a ISO13485 compliant QMS.

Know-how, skills and mindset

 

At Medicologic we know all about the challenges of finding talent and the right skill-sets for the tasks.

Medicologic was founded in 2000 by the present CEO Michael Funder, and through more than 20 years we have strived to find the greatest talent and the most skilled specialists for the medical device industry.

Our goal is to create the best scenarios for our clients, and combine our talent and specialists with the goals and budgets at hand.

We strive for customer-service excellence – and a part of this is providing a service, that gives our clients full flexibility to pull on our various ressources on any given time.

The expectations in the medical device market are high with increasing focus on patient safety and treatment methods.
Our team of dedicated freelance consultants and specialists help you develop solutions that meet the expectations, requirements and challenges in the medtech and pharma markets.

Contact

Medicologic A/S
Arne Jacobsens Alle 15-17
DK-2300 København S
Denmark
(+45) 48 24 51 13

 contact@medicologic.com
 Medicologic-profile
Where to find us

Michael Funder
Owner / Director
(+45) 20 64 41 46
mf@medicologic.com

Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05
lba@medicologic.com