Premium Organizational Management Services

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Premium Organizational Management Services
www.mavenprofserv.com
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Overview
Introduction A new beginning of continual
compliance The Solution - Leave it to the
Experts!
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Introduction
External solutions that can assist you in
regulatory submissions for your certification and
registration activities are readily available
through regulatory consultancies They not only
free you from your regulatory effort but make the
process so much faster and hassle-free without
having to invest in upgrading your resources with
the evolving regulations and requirements. But do
you really think that is enough?
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Do you think successfully getting certifications
and registration is the end goal of regulatory
compliance? Do you think, it is a smooth journey
ahead by merely having a certificate in hand?
What do you think should be the next major
objective in your regulatory journey?
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A new beginning of continual compliance
Being awarded regulatory certification is nothing
but the start of a whole new journey of
demonstrating continual compliance to retain
such certificates and breeze through your
surveillance. Things to take care post
certification
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Hire resources to maintain your technical
documentation which includes updating these
documents with the revision in standards, annual
updates with the post-market surveillance data,
and keep them prepared for yearly audits. Have
resources in place to maintain your quality
management system and simultaneously upgrade your
systems and processes to reduce product and
process non-conformities thereby increasing the
yield and reducing rejections.

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Post receiving the certificate, one starts
expanding their business to other countries and
hence needs to initiate country registration
processes which have different requirements in
different countries and hence manpower shall be
needed to continuously process registration in
different countries. shall be needed to
continuously process registration in different
countries. Preparation for surveillance audits,
representing and answering to the auditors, and
closing any non- conformances that are observed
during such audits.
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Keep your resources trained and be continuously
aware of revisions in standards, guidelines, and
changing requirements. Ensure Post-market data
is being collected adequately and analyzed to
identify any emerging risks or further scope of
improvement in the product based on collected
complaints or feedback. Constantly look for
adverse events, and vigilance activities
happening across the globe with similar devices
and take any preventive action if necessary.
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The list of such necessary actions to be taken is
endless and having an in-house regulatory
department with a minimum of 2-3 full-time
employees completely dedicated to RA functions
becomes unavoidable and it is needless to say
that these employees must be kept updated and
trained at all point and we can still not be sure
if our efforts are enough.
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The Solution - Leave it to the Experts!

• Take a premium advantage of MAVEN's Premium
  Organisational Management Services. One of its
  kind and first time in India, a consultancy that
  is constantly keeping an eye on gaps in medical
  device manufacturing industry and is
  continuously engaged in curating solutions to
  bridge this gap and help manufacturers' compete
  on a global level with improved processes and
  systems making everyday within the organisation
  an audit compliant day.

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These services are only for clients who are
completely invested in making their plant highly
compliant and are ready to consider regulatory
compliance an important parameter for their
organisational success and make necessary
resources available to achieve the same.
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Contact Us
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management-services/ business_at_mavenprofserv.com
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