Consulting Services

We team up with our clients in the development, implementation and maintenance of an effective Quality Management System in compliance with following standards and regulatory requirements:

ISO 13485:2003 (also could be integrated with 9001:2008 and other standards)

ISO 9001:2008 (also could be integrated with ISO 22001, 14001 and other standards)

Canadian Medical device Regulations (CMDR)

European Medical Device Directives (CE) e.g. 93/42/EC etc.

FDA's QSR 820

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Alex English, Quality Manager, Iotron Technologies."I just wanted to convey how impressed we were with your knowledge of ISO 13485 and 9001:2000 system. You were extremely thorough in the inspection of our system..."

12 Dimarino Drive

Brampton - ON

L6P 1W9

Canada

Tel.: 416 919 9218

info@qualityworkforce.ca

Management system development experts

We provides assistance in development of a quality system that will meet both our client and concerned regulatory agency requirements e.g. ISO 9001:2008, ISO 13485:2003, ISO 22000, ISO 14000, cGMP, Health Canada, FDA etc. Our core consulting activities includes:

Conducting a gap analysis
Developing a plan for becoming compliant
Helping to design a documented quality systems
Writing needed documentation
Managing the implementation of documented system
Training of concerned company employees
Training of internal auditors and/or conducting the internal audit

We believe our consulting responsibility goes beyond assessment and recommendation. Our consultants will assure that your objectives are translated into measurable performance improvement and bottom-line results.

medical device industry

We have helped number of leading medical device manufacturers using following steps:

Consulting in meeting the essential & conformity route
Preparing a technical file / adaptation of QMS
Selecting and Preparing for notified body audit
Self declaration etc.