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. 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. Such situations often lead to manufacturers facing Major non-conformities and in some cases cancellation of certificates.

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. 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.

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.
• The first visit is planned where the team personally visits the client, a site inspection is done, the status of the documentation is verified, the client data is collected and necessary recommendations are made.
• 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.