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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:

• 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.
• 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.
• 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.

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.

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.

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.