Medilab Consult UK
Medilab Consult

Counseling and assistance

Inspirered by many years.of experience in the medical device industry

Book my exspertise

I am offering


Counseling


Primarily small and medium-sized companies that manufacture medical devices in Class I & Class IIa and advice on building quality management systems, technical files, safety testing and certification.


Building


Building the QMS and processes within ISO 13485. (e.g. in D4 infonet)

Change Order, Audit, Risk, CAPA and Validation systems. (e.g. in D4 infonet)

Help with management during safety testing of medical equipment



PRRC function


I'm certified and registred as PRRC


Auditing


Certified Lead Auditor within ISO 13485 & ISO 9001

About me


2 May 2023, I quit as quality manager at Heka Dental to retire.

In order not to completely stagnate in my retirement, I have decided to keep my head sharp with a few days of work a week. I have therefore set up a small consulting company for the purpose.

Here I will offer small and medium-sized companies, advice and help in preparing documentation within:

Structure of QMS and processes within ISO 13485. (e.g. in D4 infonet)

Change Order, Audit, Risk, CAPA and Validation systems. (e.g. in D4 infonet)

40 years of experience in quality management, including 30 years of experience in the production of medical equipment and ISO 13485

Extensive experience with safety testing of medical equipment. (NEMKO)

Lead auditor certified

I have PRRC authorization and can offer this function.

Has spent the last 10 years working with regulatory documentation and building Technical files. The MDR regulation since the start in May 2021.

Why choose me?


Quality craftsmanship & extensive experience


40 years of experience in quality management, including 30 years of experience in the production of medical equipment and ISO 13485

Has spent the last 10 years working with regulatory documentation and building Technical files. The MDR regulation since the start in May 2021.

Collaborates with consultants within Clinical evaluation, Biocompatibility and Usability.


Carrying out functions


Can offer handling of functions such as. Quality manager

PRRC


Free offer


Preliminary meeting is always free. Here, the nature of the work is agreed and the terms of the agreement are drawn up.

Success stories


Good cooperation and a friendly approach throughout the process. The task was solved efficiently and the expertise clearly shone through, thank you!


― Anders Krog


Someone who says something nice about what you do is worth its weight in gold. Click here to add a quote from a customer..


― pending


Someone who says something nice about what you do is worth its weight in gold. Click here to add a quote from a customer.


― pending

Contact me

If you have any questions or concerns, we are always here to help!


 
 
 
 
Medilab Consult