Hoff&Lowendahl AB

We are Quality and Regulatory Affairs consultants
Our philosophy is to try to make it easy as possible for our customers!

The regulatory requirements increasing every year and it applies to both product specific requirement and management systems. We can help you with all aspects throughout the product lifecyckle, from creating a regulatory plan for the product and the company, to develop a customized quality managment system but also make or arrange contacts with authorities in all major markets to ensure market access.

We have the knowledge and expertise in:
– Quality systems(ISO13485, ISO9001, ISO 27001 and ISO 14001)
– Medical devices (all classes)
– IVD och laboratoryequipment
– Measure and test equipment
-Handling of authorities in all major markets.
-Market access in all major markets.
Registered AR within EU and PRRC for companies

Company’s Keywords:

myndighetshantering, market access, audit, mdr, management systems, ivdr, consultant, regulatory affairs, authorised representative, prrc, dd