Sound product data is essential in
complying with regulations on medical
and surgical devices
Product communication relies on accurate product information, delivered to the right place, in the right format, at the right time.
This overview offers insights into key issues in product information compliance in the medical industry, including:
- 21 CFR Part 11 compliance: to retrieve, assemble, and publish the information needed to document best practices and provide evidence of compliance
- Medical product labeling: to centrally manage product data, reduce errors when using and re-using label artwork, and produce customized labels for OEM customers
- ePedigrees: to properly manage RFID/EPC data to ensure it's accurate and up-to-date so that any application or report that uses the data is reliable
Makers and distributors of medical devices must comply with a wide range of regulations that affect the way they manage and communicate product information. However, many companies are discovering that their product information isn't ready to meet the requirements for sound compliance management.
- The data isn't clean and doesn't conform to consistent standards for naming and normalization.
- The data resides in legacy systems such as ERP and PLM applications. Product specialists have to manually extract product specs and port them to the systems that need them.
- Product teams also have to track down the photos, diagrams, and other digital assets related to each product. These assets have to be reviewed for currency and manually associated with the relevant products.
- Perhaps most important, the product content must be managed and published in ways that comply with regulations on product communication. The proper personnel must review and approve it prior to distribution. It must be available on demand when needed to demonstrate compliance. And, it needs to be output in formats such as XML to support a wide spectrum of reporting requirements.
Master data management: helping ensure compliance with regulations on product communication
A useful tool for compliance is a master data management platform. A product master data management system enables medical device companies to centrally manage their product data and related digital assets. They can also publish that information to sales and marketing channels in ways that comply with industry regulations on product communication.
In addition to reducing risk and making compliance-related processes more rigorous, master data management lowers the cost of legal and compliance services. Avoiding risk, reducing costs, and ensuring information accuracy are key reasons medical device companies should consider a product MDM initiative.
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