MDSAP is a technique through which medical device makers may be inspected once for conformity with the different medical device markets standards and regulatory requirements. 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 minimizes the overall number of audits or inspections and optimises the time and resources spent on audit operations for many medical device manufacturers. https://mavenprofserv.com/mdsap/

1. MDSAP
www.mavenprofserv.com

2. Content
MDSAP
Regulatory Authorities involved with MDSAP
Potential Benefits of MDSAP
MDSAP Certification Steps

3. MDSAP
MDSAP is a technique through
which medical device makers
inspected once for
with the different
may be
conformit
y medical device
standards
markets’
and regulatory
requirements.

4. Regulatory Authorities involved with
MDSAP
Australia: Therapeutics Goods Administration
(TGA)
Brazil: Brazilian National Health Surveillance
Agency (ANVISA)
Canada: Health Canada (HC)

5. Japan: The Ministry of Health, Labour and Welfare (MHLW)
United Sates: US Food and Drug Administration (USFDA)

6. 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.

7. 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.

8. 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.
1.Enhanced auditing organization recognition criteria,
2.Monitoring of auditing organizations by the participating
Regulatory Authorities,
3.The use of a standard MDSAP audit model,

9. 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 organization’
s
requirements.
Creation of a quality system required to fulfil regulatory
and corporate criteria.
MDSAP Certification Steps

10. 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 MDSAP’s process-based approach
of Auditing.
Application for MDSAP with a fully recognized Auditing
Organization.
Audit support during Initial Certification Audit.

11. Contact Us
https://mavenprofserv.com/mdsap/
business@mavenprofserv.com
enquiry@mavenprofserv.com