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 Details
- Founded
- -
- Address
- Högåsvägen 125, Knivsta,se-74141,sweden
- Industry
- Medical Device
- Website
- lowendahl.eu
- Keywords
- Regulatory Affairs, Management systems, Market access, Audit, DD, PRRC, Authorised Representative, MDR, IVDR, Myndighetshantering, Consultant.
- HQ
- Knivsta
- Competitors
- Invent Medic Sweden AB.
Hoff&lowendahl Ab Questions
Hoff&Lowendahl Ab's website is lowendahl.eu
Hoff&Lowendahl Ab's LinkedIn profile is https://se.linkedin.com/company/hoff&lowendahl-ab
Hoff&Lowendahl Ab's industry is
Medical Device
Hoff&Lowendahl Ab's top competitors are
Invent Medic Sweden Ab.
Hoff&Lowendahl Ab's categories are Medical Device
Hoff&Lowendahl Ab's founding year is 2016
