QMS & Regulatory Consultancy for Medical Device and IVD Manufacturer & Importers

We offer our services to companies of every size for SMART implementation of QMS and regulatory compliance requirements and a host of other services.

Services

MFG Facility
Design / Upgrade

Clinical Investigation
Clinical Performance Evaluation

QA / Regulatory
Document Design

Preparedness for
Certification

About us

Intrust-Consulting helps Client’s Team to Conceptualize, Build, Implement and Operate a Quality Management System fulfilling all Regulatory requirements. Our approach of consultancy is simple, easy to understand, inculcate and is enabling your team for future.

Our consultancy leads to a well-designed “Integrated Quality Management System” which becomes one step solution for your global compliance corporate Quality Objective. Once implemented your registrations, accreditations come with ease.

Indian Medical Device Regulation

Build Smart QMS

Help you Design, Implement and Manage the QMS fully customized through the extent of your organization. We also Improve health of your implemented QMS

Intent Resources Process Approach PDCA

Smart
Implementation

MDSAP/CE Marking
Customer Satisfaction
Regulatory Compliance

Mission

Inform, Reform and Transform the QMS through cross functional involvement during consultancy period.

Vision

Our client shall achieve the TRUST of Regulation IN Medical Device & In Vitro Diagnostic Devices.

Niche

Techno-QMS-Regulatory experience in MD & IVD Domain (Cumulative Working Experience of >50 years)

Our Core Values support your
Quality & Regulatory Aims

Our Diversified Clientele

3 Steps to Certification

With the help of QMS, the certification process can take as little as 120 days to complete

A QMS Consultant will visit your Organisation to review and document (GAP Assessment)

Now its time to make sure any required process or procedural changes are made, as highlighted in the Review. QMS can provide templates to assist you in doing this.

Now you are ready for audit by your selected notified body. Once they are satisfied, you will be rewarded with your certification.

Smart Route To Your Certification

Keep in touch

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