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Sushvin Consultancy Services Ltd Sushvin Consultancy Services Ltd logo

Address :
210d, Sundon Park Road,
Luton,
LU3 3AL,
United Kingdom
Telephone :
+44 7867782018
Website :
Description :
Sushvin Consultancy Services is a Global Medical Device Consulting Firm and a leading provider of strategic Regulatory and Quality Compliance Services for Medical Device and In-vitro Diagnostic (IVD) devices including Software as a Medical Device (SaMD). Sushvin Consultancy Services help manufacturers achieve CE marking for their products. We are an expert consultancy for ISO 13485 QMS compliance, MDR/IVDR compliance, UKCA marking and FDA and Global Registrations.

Our Regulatory Services cover regulatory strategy and compliance, quality assurance and compliance, technical file preparation and regulatory submissions, clinical evaluation reports, guidance and support for the MDR/IVDR Regulation, drug/device combination and borderline products, vigilance and post market surveillance, labelling and staff training.

Sushvin Consultancy Services has been in the medical device industry for over 10 years and specializes in quality and regulatory compliance in the UK, EU, US, Middle East, South Asia and rest of the world.

Our team of experienced professionals have helped many clients bring their products to market successfully and efficiently. Our team of experts will help you navigate the complex regulatory landscape and ensure that your products meet the highest standards of safety, quality and performance. With our specialized services, you can just sit back relax while we do all the heavy lifting to ensure that your medical devices are compliant to global quality, regulatory and safety requirements