Quality & Regulatory

Compliance!!! Yes, this is the most frequent and important word you may have been hearing all along if you are engaged in a business which is regulated by government or private entities. Whether it is ISO certification or manufacturing a high-risk medical device, the first thing you must make sure is, you are in compliance with all internal and external regulation.

Did you know that your own procedures and/or work instructions you write for your day to day manufacturing/operation process could lead you up to a nonconformance if they are not followed accordingly?

Do you have sufficient quality system in place to cover you from an audit finding? How robust is your quality system? Is your quality system up to the industry standard? What control do you have in place to make sure that your organization complies with all internal and external requirements?

To find these answers, we are here to help. See where we can help with our specialized expertise:

 

Our Specialties

We offer following specialized services to our clients:

    ✪    Quality System Audit (21CFR Part 820 & ISO 13485)

    ✪    Product Quality Audit

    ✪    Supplier Quality Audit

    ✪    Audit Ready Consultation (21CFR Part 820 & ISO 13485)

    ✪    Quality System Remediation

    ✪    Quality System Implementation- Turnkey Solution

    ✪    Successful Audit Management – Tools & Technics

    ✪    SCAR & CAPA

    ✪    Customer Complaints

    ✪    Non-Conforming Material Management

Please  contact us  for more details.