Integrated Quality Management System

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INTEGRATED QUALITY MANAGEMENT SYSTEM
www.mavenprofserv.com
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OVERVIEW
Introduction Canada- QMS requirements for medical
device companies MDSAP and Health Canada USA QMS
requirements for medical device companies MDSAP
and USFDA How maven help you in Integrated
Quality Management System?
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Introduction
An Integrated Management System (IMS) integrates
all of an organizations systems and processes
into one complete framework, enabling an
organization to work as a single unit with
unified objectives. Experience seamless quality
control with our Integrated Quality Management
System. Elevate efficiency and productivity
effortlessly.
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Canada - QMS requirements for medical device
companiesd

• Under MDSAP, manufacturers of Class II, III, and
  IV medical devices must demonstrate ISO 13485
  compliance. The QMS requirements of the Canadian
  Medical Devices Regulations (CMDR) are included
  in the MDSAP. Before your device can be sold in
  Canada, a Health Canada and MDSAP-accredited
  Auditing Organization (AO) must certify your
  MDSAP-compliant quality system. As of January 1,
  2019, MDSAP compliance is mandatory.

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MDSAP and Health Canada

• As part of their Canadian Medical Device
  Conformity Assessment System (CMDCAS)
  accreditation programme, Health Canada will
  conduct an MDSAP audit. Upon the successful
  completion of the pilot, Health Canada intends
  to establish the Medical Device Single Audit
  Program as a means to achieve regulatory
  compliance for quality management system
  requirements in Canada.

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USA QMS requirements for medical device
companies A document outlining the current good
manufacturing practises (CGMP) requirements is
the FDA 21 CFR Part 820, often known as the
Quality System Regulation (QSR). This document
oversees manufacturing processes to guarantee
that their goods comply consistently with
applicable specifications and regulations. The
quality system approved by the FDA is FDA 21 CFR
Part 820. These guidelines are designed to
assure safe and effective medical devices.
Medical device makers to ensure compliance with
FDA 21 CFR 820 conduct FDA inspections.
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MDSAP and USFDA

• FDA will accept the MDSAP audit reports as a
  substitute for FDA routine inspections.
  Inspections conducted for cause or compliance
  follow-up by FDA will not be affected by this
  program. Moreover, the MDSAP would not apply to
  any necessary pre-approval or post-approval
  inspections in support of Premarket Approval
  (PMA) applications.

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How MAVEN help you in Integrated Quality
Management System?
MAVEN specializes in medical device regulatory
compliance. Our consultants have assisted medical
device companies worldwide with ISO 13485 QMS
integration with 21 CFR and MDSAP. A MAVEN
quality management system complies not only with
ISO 13485, but additional medical device
regulatory requirements in many other markets.
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In addition to ISO 13485 consulting, we can
assist with medical device licenses and
establishment licensing in various countries.
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Contact Us
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