Eurotech Assessment & Certification Services Pvt. Ltd.

Eurotech is a UK based Leading Certification Company having reach all over the country and we are accredited from IABCBL(UK).

We are offering a complete solution of CE Marking and ISO certification, US FDA, FSC services including Technical Guidance, Documentation, Testing, Pre Audit & Audits and Certification.

Our scope for CE certification by the following directives:

• Medical Device Directive,
• Pressure Equipment Directive
• Transportable Pressure Equipment Directive
• Simple Pressure Vessels Directive
• Lift Directive
• Machinery directive
• Low Voltage Directive
• EMC Directive
• In-vitro Device Directive
• Active Implantable Medical Device Directive
• Construction Product Directive
• Heavy Machinery/Equipments

How to Procure a Free Sale Certificate for your medical devices:
A FSC is issued by a European Competent Authority upon request by an European Authorized Representative on behalf of a medical device manufacturer. The FSC certifies that your medical device may be legally marketed in the European Union. EAR service can request FSC documents on behalf of our clients. Medical device markets for which Eurotech has secured FSC documents for clients include:

• Egypt, Ecuador, Colombia, China, Chile, Brazil, Bolivia, Australia, Argentina, India, Japan, Iraq, Mexico, Sri Lanka and many more.
• Eurotech Certification has the resources and experience to secure your Free Sale Certificate
• Eurotech acts as Authorized Representative(EAR) for many medical device companies selling their products in Europe. In this capacity, Eurotech can request a FSC from the Competent Authority as efficiently and quickly as possible:
• We have offered European Authorized Representative services since 2007.
• We are present in both Europe and many of the markets that require a FSC.

Please contact us for more information on our Free Sale Certificate (FSC) service.

We also Provide SEDEX & BSCI Auditing (Social Audits) Services.
Other services provided by us:

• ISO 9001, ISO 14001, OHSAS 18001, ISO 20000, ISO 22000, ISO 27001, ISO 13485
• EAR : European Authorised Representative
• SA 8000
• ROHS Certification
• Customized Training
• Testing

We also provides the following Services in India and abroad for medical device manufacturers and traders.

Product certification (CE Marking)/MDQMS (ISO 13485), Clinical Investigation/trial, GMP Compliance certification ,European authorized representative (EAR), US FDA consulting.

Also, to inform you that we are having a NABL approved (Certificate No. T 1811) sister concern testing laboratory Known as ITC INDIA performing Electrical Safety Testing for the following:

• EMC/EMI Testing
• Machinery Equipments Testing  
• Luminaries and Lightning
• Electro Medical Equipments
• Laboratory Equipment
• Household Appliances
• IT and Telecom Equipment
• Environmental Testing
• Battery Testing.