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Product Risk & Clinical Evaluations

Product Risk Analysis and Clinical Evaluation, Design file, ER / GSPR Report

Social Accountability -:

Social accountability requires people and organizations and institutions to accept responsibility for their actions which affect society and the environment and all stakeholders. The requirements for this standard extend beyond legal compliance because it needs organizations to demonstrate ethical conduct and maintain transparency while working to achieve social benefits.

The concept originated primarily in the context of governance, focusing on mechanisms that citizens can use to hold public officials and service providers accountable. Companies must balance their profit motives with their responsibility to protect people and the environment which connects business operations to Corporate Social Responsibility (CSR) and sustainable development.

A). SA 8000-

We provide a single source solution which delivers all the services you need to decrease risks associated with SA 8000 certification. SA8000 is a specific, verifiable certification standard for social accountability developed by Social Accountability International (SAI) [1]. The framework enables organizations to show their dedication towards fair worker treatment and their compliance with established international labor standards.

The standard serves as an internationally recognized social certification system which allows for complete auditability of its various components. The standard addresses essential aspects through its examination of child labor, forced labor, health and safety, freedom of association, discrimination, and working hours.

B). SED EX-

The organization operates as one of the top ethical trade service organizations which leads the world in its efforts to establish responsible business practices throughout international supply networks. The organization operates a secure web platform called Sedex Advance platform which allows member companies to store and share their ethical and responsible sourcing data. SEDEX enables organizations to handle their environmental and social responsibilities through its four main operational areas of Labour Standards Health Safety Environment and Business Ethics.

DETAIL OF ERVICES

Services Offered

ISO & International Certification Services

We offer comprehensive Consultancy Services for Certification and Compliance from internationally recognized accreditation bodies, including:

  • ISO Standards: 9001, 14001, 17025, 13485, 20000, 22000, 27000, 50001
  • OHSMS 45001
  • TS 16949 IATF 16949
  • SA 8000 Social Accountability
  • BRC British Retail Consortium
  • HACCP Hazard Analysis and Critical Control Points
  • GMP WHO-GMP Good Manufacturing Practices
  • CE Marking UNDER EU MDR2017/745 EU MDR2017/746
  • UL Certification Underwriters Laboratories
  • CMM CMMI Capability Maturity Model Integration
  • NABH National Accreditation Board for Hospitals
  • NABL National Accreditation Board for Testing and Calibration Laboratories
  • Manufacturing License Applications:
    • Class A & B Devices – Form MD-3 / MD-5
    • Class C & D Devices – Form MD-7 / MD-9
  • Import License Applications:
    • Class A, B, C & D Devices – Form MD-14 / MD-15
  • Test Licenses:
    • For Domestic Testing – Form MD-12 / MD-13
    • For Imported Samples – Form MD-16 / MD-17
  • Site Master File (SMF) and Device Master File (DMF) require preparation work.
  • The team will handle all regulatory submissions while they coordinate with CDSCO through liaison activities.
  • The team provides technical documentation support to clients according to GHTF format requirements.
  • The team provides support for post-approval processes while managing license renewal procedures.
We are medical device consultants and our focus areas are MDR, IVDR, GMP, CE Mark, UKCA Mark, FDA 510k, ISO 13485, and 21 CFR 820 compliance, and more.
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