The EXPERT knowledge partners for all Global Regulatory Compliance Processes in various domains like Medical and Healthcare, Industrial, Automotive, Energy, Environment, IT, Communications etc.
Can offer professional consultancy services worldwide, with the backing of core domain expertise of overall 200+ man-years in Regulatory Compliances, Product Certifications, Auditing, Consulting and Training for Quality, Safety and Environmental Management Systems in various verticals.The consulting scope includes compliance to national as well as international Regulatory, Quality and Safety compliances like MDD, USFDA, CE Mark, PMA/510k notification, CB Scheme, FCC, CCC Marks, JAS Marks, S Mark, ISI Mark and many more.
One of its kind - the very rarest Regulatory Compliance Consulting partner that is capable to support the clients with end to end solutions including compliance testing through its own group Test Laboratory.
We offer you the rarest services in various verticles.
Consultancy for National/International Regulatory Compliances to
- Global directives such as MDD, LVD, PED, MCD, USFDA
- Compliance to Safety/Quality Marks like CE, S, ISI, CCC etc
- 510k Notification, Premarket Approvals
- Specific EU Standards, US or Other country Codes like IEC standards, 21CFR
- Risk Assessments, Software Validations, Usability Engineering
- Compliance to Quality/Safety management systems like ISO 9001, ISO 13485, ISO TS 14949
- Identifying applicable Regulatory requirements
- Identifying applicable Standards
- Determination of applicable Test requirements
- Product Review and Verification
- Product documentation review and verification
- Guidance on Testing
- Development support for product improvements if any
- Pre and FUll compliance Testing
- Identify Documentation requirements
- Documents review
- Support in Drafting Policies, Quality Manuals, Procedures, Work Instructions
- Guidance on Generating Quality Plans and Quality Records
- Support on Technical File Construction
- Special Reports like Risk Management, Clinical Validation, Software Validations
- Professional Writing Servies for Technical Documents writing
- Quality Manual, Quality Policy and Procedures
- Quality Record Formats and sample records
- Technical File Contents e.g. Declaration of Conformity, Essential Requirement Check List, Classification, Technical Description, Specifications etc
- User Instructions, User manuals, Service Manuals
- Risk management Reports
- Clinical Evaluation Reports
- Inhouse Test Reports e.g. Software Validation as per IEC 62304, Internal Test reports for Colateral Standards
- Quality Management Systems e.g. ISO 9001, ISO 13485, ISO 17025, TS/ISO 14646
- Regulatory Directives - LVD, PED, MDD, MCD, 21FCR
- Product Certification Requirements - CE Marking, 510K notifications
- GMP, GLP
- Documentations
- EMI/EMC
Consultancy for
- Environmental Management : ISO 14001
- Green House Gases : ISO/GHG 14064
- Automotive QMS TS/ISO 14949
- Competency of Testing and Calibration Laboratories : ISO 17025
- Occupational Health & Safety Management System OHSAS/ISO 18001 series
- Food Safety Management FSMS/ISO 22000 series
- Information Security Management System : ISMS/ISO 27000 series
Excel with your very own Expert Knowledge Partner for any of your Regulatory Compliance Requirements!
