Product certification or product qualification is the process of verifying that a certain product has passed performance tests and quality assurance tests or qualification requirements stipulated in contracts, regulations, or specifications. For example, it may relate to a building code, nationally accredited test standards, or a set of regulations governing quality and minimum performance requirements. Certifications (and the certificates that document their existence) are often called certs in the everyday jargon of various industries.

 

ISI Mark (Indian Standards Institution )

 

Formulation of Indian Standards for products and services by bringing together and coordinating various interest groups like manufacturers, consumers, technical experts, testing personnel and others interested. The standards so prepared are known as Indian Standards (IS) and are considered as legal documents. The first Indian Standard formulated was for the National Flag (IS 1). So far BIS has published about 18000 Indian Standards covering various products, codes of practices, terminology, etc for various industrial and economic sectors. The Indian Standards are used not only by the industry but also by the Government, students, consumers and regulatory authorities. The standards are priced publications and are available from all the offices of the Bureau.

 

CE Marking

 

Sai IP Consult Solutions provides support to medical device companies that are seeking CE regulatory approval for their products in Europe. Saiipconsult consultants have a wealth of experience in the preparation of regulatory submissions required to obtain CE marketing clearance and have built strong relationships with the Notified Bodies. Qserve can help you bring your product to the market faster, minimizing the time and costs involved, and maximizing your product revenues.

 

"CE Mark" means that the product is safe and fit for the purpose for which it was made. Medical Devices Directives (MDD) specify requirements which must be met before permission is granted to apply the CE marking to your medical device and placing it on the market. The Directives which apply to medical devices are

 

Active Implantable Medical Device Directive (90/385/EEC)

 

This directive covers all medical devices, which rely on a power supply to function and that are left in the human body. These include implantable cardiac pacemakers, implantable nerve stimulators, etc

 

Medical Device Directive (93/42/EEC)

 

The Medical Device Directive covers most other medical devices (active and non-active) and their accessories that are not covered by the first or the third directive. This concerns a large number of products ranging from walking aids to prosthetic heart valves.

 

In Vitro Diagnostic Medical Device Directive (98/79/EC)

 

The In Vitro Diagnostic Medical Device Directive will cover any reagent, reagent product, control material, kit, medical device, instrument, apparatus or system which is intended to be used in-vitro for the examination of substances derived from the human body