Quality Assurance

Your company’s quality assurance, and your processes and quality management is key for go-to-market – and making sure the products are able to stay on the market.

QA – ensuring quality, always

Strengthening the backbone of your business
At Medicologic we take great pride in providing top-class consultants to the medical industry.
With every new product development, R&D process and chain of supply – the quality assurrance and regulatory affairs is of the outmost importance.
We help you with the process, validation, management, and maintenance of your quality assurance.
We have listed our wide range of skills and experiences we can provide through our extensive catalogue of consultants – feel free to reach our to us, if you see potential or have any questions.

List of skills and experiences:

  • QA Validation.
  • Quality Assurance.
  • CAPA and Compliance.
  • Qualification and Validation.
  • Quality assurance sample testing, test plans.
  • Quality Management Systems:
    ISO 9001, ISO 13485
  • IT-system for QA. 
  • QMS management:
    FDA 21 CFR part 820
    In vitro diagnostics and medical device regulations (MDR/IVDR).
  • GMP (Good Manufacturing Process) and Quality Assurance (QA).
  • cGMP.

  • Design Control and MDR transition.
  • MDSAP certification.
  • Aligning QA strategies with Business goals.
  • Training and implementation of SOP’s in global scale.
  • Legal entity transfer.
  • Preparing for IVDR and MDR.
  • Active & Certified Lead Auditor; external/internal audits.
  • Supplier Quality Management.

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