We Ensure Best Service
ISO 13485 is a quality management system standard that requires an
organization to demonstrate its ability to supply Medical Devices and
related services that consistently meet customer criteria as well as regulatory
obligations. The ISO 13485 standard is the de facto standard for regulatory
compliance in the medical device industry.
Benefits of implementing ISO 13485 Quality Certification for both Clients and the Organizations:
- Quality ensured medical devices.
- Safe and effective medical devices.
- Lower scepticism and increased confidence for the end customer.
- Boost loyal and potential customers.
- Global Recognition.
- Cost Savings.
- Improved product safety.
- More Effective Risk Management.
- Improved legal and regulatory or contractual requirements compliance.
- Proactive error detection and prevention.
- Increased likelihood of meeting Customer Requirements.
- Increased Efficiency and Profit Margins.
- More Effective Risk Management.
- Assistance in monitoring supply chain effectiveness.
Clients Testimonials
We engaged Echelon Consultancy because we wanted to build a robust and effective management system within our organization.
“Echelon Consultancy is engaged with us since 2011, they have wonderfully helped us to integrate our management systems, trained our people and help build a positive culture within the organization”
“We began working with Echelon Consultancy because we wanted to implement Integrated Management Systems effectively and efficiently”
“We had appointed Echelon Consultancy in the year 2015 as we were facing lots of challenges in managing our processes. They have not only helped us in solving those challenges, but also help build a positive culture within the organization.”
- ISO 9001:2015 – Quality Management Systems
- ISO 14001:2015 – Environment Management Systems
- ISO 45001:2018 – Occupational Health and Safety Management Systems
- ISO 22000:2018 – Food Safety Management Systems
- ISO 15378:2017 – Primary Packaging Materials for Medicinal Products
- ISO 13485:2016 – Medical Devices Quality Management Systems
- ISO 22301 – Business Continuity Management System Certification
- ISO 22716:2007: COSMETICS — GOOD MANUFACTURING PRACTICES (GMP)
- ISO 50001 – Energy Management Systems
- SEDEX – Supplier Ethical Data Exchange
- SMETA – SEDEX Members Ethical Trade Audit
- FSSC 22000 – Foundation Food Safety System Certification
- BRC – British Retail Consortium