Best Consultancy for MDSAP in Australia

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MDSAP
www.mavenprofserv.com
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Content
MDSAP Regulatory Authorities involved with MDSAP
Potential Benefits of MDSAP MDSAP Certification
Steps
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MDSAP
MDSAP is a technique through which medical device
makers
inspected once for with the different
may be conformity medical
device
markets and regulatory
standards
requirements.
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Regulatory Authorities involved with MDSAP
Australia Therapeutics Goods Administration
(TGA) Brazil Brazilian National Health Surveillan
ce Agency (ANVISA) Canada Health Canada (HC)
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Japan The Ministry of Health, Labour and Welfare
(MHLW) United Sates US Food and Drug
Administration (USFDA)
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Potential Benefits of MDSAP

• Multiple individual audits or inspections by
  participating regulatory bodies or their
  representatives are replaced by a single audit.
  As a result, the Medical Device Single Audit
  Program minimises the overall number of audits or
  inspections and optimises the time and resources
  spent on audit operations for many medical
  device manufacturers.

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As a long-term goal, it is expected that the
programme will increase trust in the reliability
of third-party audits, that more Regulatory
Authorities will join the programme, and that
other Regulatory Authorities will use the
information made available through the programme
to reduce the need for additional audits. Some
participating regulatory agencies may utilize
MDSAP audit results instead of their own
inspections to process medical device marketing
authorization applications.
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• The medical device manufacturer, like any other
  third-party auditing programmed, is free to
  select any recognized auditing agency to execute
  the audits. Routine audits are announced and
  organized in collaboration with the
  manufacturer.
• Enhanced auditing organization recognition
  criteria,
• Monitoring of auditing organizations by the partic
  ipating Regulatory Authorities,
• The use of a standard MDSAP audit model,

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MDSAP Certification Steps
Gap Analysis for your existing QMS. If you
already have other QMS certifications, for e.g.
ISO 13485, ISO 9001, WHO GMP or 21 CFR 820,
experts at Maven can help you prepare an
integrated QMS covering the requirements of all
the regulatory bodies. Preparing SOPs according to
your organizations requirements. Creation of a
quality system required to fulfil regulatory and
corporate criteria.
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Identification of requirements from markets of
different countries required for MDSAP
Certification and incorporating the same into
the QMS. On ground implementation of the Quality
Procedures and practices. Mock Audits based on
MDSAPs process-based approach of
Auditing. Application for MDSAP with a fully
recognized Auditing Organization. Audit support
during Initial Certification Audit.
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