Quality Assurance

Quality assurance ensures a company’s products meet quality standards for distribution to the market. We ensure that the quality of products are maintained at a desired level
especially by means of attention to every stage of the process of delivery or production. Our quality assurance team prevents mistakes and defects in manufactured products and avoiding problems when delivering products to customer.

  • Clause-wise assessment for applicability & compliance for ISO 13485 Medical device Quality Management System (QMS) Process
  • Clause-wise assessment for applicability & compliance for ISO 14971 Medical device Risk Management Process

Environmental Compliance

Environmental Compliance means conforming to environmental laws, regulations, standards and other requirements to operate. In recent years, environmental concerns have led to a significant increase in the number and scope of compliance imperatives across all global regulatory environments.

REACH

REACH (Registration, Evaluation, Authorization and restriction of Chemicals) is a European Union(EU) regulation aimed at improving protection of human health and the environment from the risks of chemicals. Industry must  be responsible for safe manufacture and use of chemical substances. Our team provides guidance to help companies comply with the requirements of the REACH regulation and that they possess all supporting documentation. With the changing SVHC list, our team contacts the suppliers to get updated certifications, to keep the compliance data fresh and accurate.

TYPICAL REACH PROJECT ACTIVITIES INCLUDE

  • Bill of material assessment
  • Engineering review of supplier declarations
  • Project management & report
  • Documentation & technical file creation
ROHS COMPLIANCE

Our RoHS (Restriction of Hazardous Substances) compliance services provides comprehensive solutions that enable companies to meet their environmental compliance obligations on time. iLenSys helps the business units to analyse their Bill of Materials,identify the non-compliance electronic components and ensure their products are RoHS compliant and that they possess all supporting documentation in accordance with due diligence.

TYPICAL ROHS PROJECT ACTIVITIES INCLUDE

  • Bill of material assessment
  • Product/Component qualification
  • Design and document update
  • Engineering review of supplier declarations
  • Project management & report
  • Documentation & technical file creation
 Waste Electrical and Electronic Equipment Directive (WEEE)

The Waste Electrical and Electronic Equipment Directive (WEEE Directive) is the European Community Directive 2012/19/EU on waste electrical and electronic equipment (WEEE) which, together with the RoHS Directive 2011/65/EU, became European Law in February 2003. The WEEE Directive set collection, recycling and recovery targets for all types of electrical goods, with a minimum rate of 4 kilograms per head of population per annum recovered for recycling by 2009. The RoHS Directive set restrictions upon European manufacturers as to the material content of new electronic equipment placed on the market.