Environmental Compliance Overview

Environmental Compliance refers to conformance to environmental laws, regulations, standards and other requirements to operate in attaining a sustainable goals, to protect the environment even when businesses continue to manufacture and reach out to several markets.

In the US alone, there are several regulations that companies need to comply with, including the Environmental Protection Agency (EPA), the Clean Air Act, the Clean Water Act, the Resource Conservation and Recovery Act (RCRA), and the Stormwater Clean Water Act.

Benefits of Environmental Compliance

Cost Reduction

Reduced Carbon Footprint

Corporate Social Responsibility

Business Profitability


REACH Regulations

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 Substances of Very High Concern (SVHC) list, our team contacts the suppliers to get updated certifications, to keep the compliance data fresh and accurate.

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 analyze 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 REACH Project Activities Include

Bill of Material  Assessment
Bill of Material Assessment
 Engineering Review of Supplier Declarations
Engineering Review of Supplier Declarations
 Project Management & Report
Project Management & Report
Documentation & Technical File Creation
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.


CE Marking Support for MDR & IVDR

Projects we support:

  • Gap Analysis
    • Clause-wise assessment and in-depth Gap analysis of existing documentation.
    • Suggest device classification, applicable Standards, and action items for bringing the documentation into full regulatory compliance.
  • Regulatory Dossiers
    • Compilation of technical files for medical devices and IVDs and assist the customer with the MDR/IVDR transition process.
  • Performance Evaluation Reports
    • Performance evaluation plan and report compilation as per IVD-Regulation 2017/746 in collaboration with the customer.
  • Scientific Validity Reports
    • Establish the scientific validity claims as per the intended purpose of the IVD device as per IVD-Regulation 2017/746.
    • Documentation of the systematic literature procedure, on scientific validity claim.
  • Third-party Testing
    • Co-ordinate with accredited testing laboratories for Safety, Compliance & Biocompatibility Testing of medical devices.
    • Analytical and Clinical Performance testing of IVDs.

Our Process Workflow


Our Strengths

  • Qualified and Experienced Resources
  • Global Regulatory Exposure
  • Our Standard Tools and Templates
  • Service Delivery Strategies
  • Defined Process and Quality Checks
  • On Time Delivery

Quality Assurance and Regulatory Affairs Capabilities

Regulatory Affairs Consultation

  • Compilation of Regulatory Dossiers
  • Gap Analysis of Documentation
  • Remediation Planning
  • Compliance to Harmonized Standards

QMS Remediation

  • Proactive Monitoring of Regulatory Changes, Supplier Quality, CAPA system
  • QMS Gap Assessment and SOPs Updates

Biocompatibility, Sterilization

  • Biocompatibility Evaluation
  • Toxicological Assessment
  • Disinfectant Validation
  • Sterilization Process Validation

IVD Specific Support

  • Performance Evaluation Plan and Report Compilation
  • Establish the Scientific Validity Claims as per the Intended Purpose by Literature Search

Product Certification Support

  • Gap Analysis of a Product
  • Construction Review of a Product
  • Approaching Third Party Lab for Testing per Standards
  • Creation of Critical Component Lists
  • Review of Test Report
  • Documentational Support
  • User Manual Review

FCC Requirements

The FCC Declaration of Conformity or the FCC label or the FCC mark is a certification mark employed on electronic products manufactured or sold in the United States which certifies that the electromagnetic interferences from the device is under limits approved by the Federal Communications Commission (FCC).

Devices classified under part 15 or part 18 of the FCC regulations were required to be labelled with the FCC mark.

CE Marking for Lab, Measurement, & Control Equipment

CE Marking on a product is a manufacturer’s declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, in practice by many of the so-called Product Directives.

CE Marking on a product ensures the free movement of the product within the EFT European Union (EU) single market (including totally 30 EEA* countries).

ICES Interference Causing Equipment Standard

Interference-Causing Equipment Standard ICES-Gen, issue 1, General Requirements for Compliance of Interference-Causing Equipment, sets out general requirements that are common and applicable to all categories of interference-causing equipment, unless stated otherwise in the corresponding ICES standard.

ICES-001 — Industrial, Scientific and Medical (ISM) Radio Frequency Generators
ICES-003 — Information Technology Equipment 
(Including Digital Apparatus) — Limits and Methods of Measurement

OSHA's Nationally Recognized Testing Laboratory (NRTL)

Recognizes private sector organizations to perform certification for certain products to ensure that they meet the requirements of both the construction and general industry OSHA electrical standards.


CB Certification

The CB Scheme is an international program created by the International Electrotechnical Commission for Electrical Equipment (IECEE) for the acceptance of product safety test results among participating laboratories and certification organizations around the world.

The CB Scheme offers manufacturers a simplified way of obtaining multiple national safety certifications for their products — providing entry into over 50 countries.


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iLenSys Technologies Pvt. Ltd.

MLA Colony, Road No: 12, Banjara Hills,
Hyderabad, Telangana 500 034
Phone: 040 – 66998246, 040 – 66998234