The annual maintenance contract (AMC) services provided by Maven Professional Services aim to assist small and micro enterprises in maintaining compliance with regulatory requirements for medical devices. These services include the management of quality systems, conducting internal audits, and ensuring timely updates on certifications and technical documentation. The AMC also offers client visits for audits and ongoing support to navigate changing regulations and manage post-market surveillance.

1. Annual
Maintenance
Contract
www.mavenprofserv.com

2. 1.
Content
Annual Maintenance Contract
AMC Services
AMC Typical Workflow

3. Annual Maintenance
Contract
As inevitable, it has become to get
regulatory certifications for medical
devices, it is even more critical to retain
and maintain the organization and its
processes in continuous compliance with
the requirements imposed by such
regulations.

4. This can be a difficult task especially for small/micro enterprises,
who do not wish to have on-board a team or a person dedicated
to regulatory compliances or for industries who do not have
employees with required expertize. It also becomes quite difficult
for manufacturers to keep up with dynamically changing
regulations and requirements put up by authorities.
Sometimes manufacturers face difficulty facing certification and
surveillance audits and usually lack representation or trying to
interpret the requirements of the reviewers and auditors. This
can even extend to failure in understanding non-conformities and
the exact corrective actions to be taken.

5. AMC Services
We acknowledge the limitations faced by such organizations and
have specially curated our Annual Maintenance Contract (AMC)
services, where we take complete charge of ensuring regulatory
compliances of all certifications held by the manufacturer.
These services include maintenance and update of quality
management system, planning and performing Internal Quality
Audits (IQA) and Management review meetings (MRM), Mock
audits, Support during audits, closure of non-conformities and
observations for both, internal and external audits.

6. We also ensure that their technical documentation is kept up-to-
date and in compliance to the regulation. We guide manufacturer’s
to collect sufficient and effective Post Market Surveillance (PMS)
data and monitor their monthly progress. We keep them updated
with information on expiration of agreements, certificates, and
validations well in time to ensure renewal and recertification are
performed timely. As a part of AMC, we offer more than five visits
to the client premises which include visits for IQA & MRM, visit for
preparation of surveillance and recertification audits, visit for
audit support and surprise visits.

7. AMC Typical Workflow
The Head- Contract Management finalizes the scope of AMC.
The Head- Contract Management then finalizes the AMC team,
with an AMC lead and another person in support.
The AMC team then prepares an annual AMC plan for the client
based on the scope. This plan also defines the time of visits
around the IQA month, surveillance audits and other events.

8. The visits are followed up by preparation of a detailed visit report
where real-time situation is conveyed to the client with
recommended actions to be taken which are later verified by
exchange of documentation or in the next visit
This is just a brief overview of the AMC service and is not limited to the
mentioned details. Our AMC clients are manufacturers of all classes of
medical devices and In-vitro Diagnostic devices. Our AMC services are
not restricted to national borders; we are global in providing this
service.

9. CONTACT US
https://mavenprofserv.com/annual-
maintenance- contract/
business@mavenprofserv.com
enquiry@mavenprofserv.com