Hoff&Lowendahl AB

medical devices

About

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

Technologies

Varnish Google Tag Manager Google Font API WordPress.org Apache Bootstrap Framework Mobile Friendly

Keywords

management systems ivdr consultant prrc dd myndighetshantering audit regulatory affairs authorised representative mdr market access eu mdr cost-effective compliance regulatory guidance for software labeling and promotion iso 9001 b2b iso 14001 authority handling global regulatory support compliance projects regulatory strategy for small manufacturers trade compliance fda submissions other scientific and technical consulting services regulatory documentation pre-submissions regulatory gap analysis fda inspections market entry strategy

Location

125 Hoegasvaegen, Knivsta, Uppsala County, Sweden, 741 41

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