Medical Device Industry and Product Lifecycle Management Solutions
The concept of product lifecycle primarily applies to medical devices, and PLM solutions available in the market today cater to device manufacturers. U.S. Food and Drug Administration (FDA) regulations and guidelines give consideration to the fact that the process of medical device development entails a cyclical and iterative process. It involves prototyping, testing and re-testing, and even re-design, before a device can be finalized. A robust product lifecycle management solution should address this cyclical and iterative nature of device development.
Regulatory bodies like the FDA greatly affect the device development process. Likewise product lifecycle management solutions are designed primarily to address existing rules and regulations.
For example, the FDA’s 21 CFR 820 incorporates requirements that ensure the safety and quality of a device in every phase of its development. Although these phases (pre-clinical, clinical, etc.) appear to be distinct, in fact they overlap. The FDA applies a “Total Product Life Cycle (TPLC)” approach in enforcement and it also maintains a TPLC database, which provides premarket and postmarket data about medical devices.
Medical device manufacturers are motivated to use product lifecycle management solutions because of the complexity of the development process, especially within the context of a total product lifecycle approach. An effective PLM solution can greatly streamline critical processes for every phase of the development and ensure a TPLC approach.
ISO Standards and Product Lifecycle Management Solutions
Most medical device manufacturers worldwide comply with ISO 13485 in addition to FDA and other country-based regulations. If they use a product lifecycle management solution, then the system must also address ISO requirements.
ISO 13485 requires medical device manufacturers to establish an effective quality management system, which would apply to the entire product lifecycle. While ISO 13485 implies the need for product lifecycle management, most device manufacturers apply those standards in conjunction with ISO 14971, which pertains to risk management. Companies looking for a product lifecycle management solution should make sure that the PLM solution they choose will address both ISO standards.
MasterControl’s Product Lifecycle Management Solution
MasterControl offers a product lifecycle management solution for a more effective and efficient management of quality processes throughout the development process: discovery, prototyping, pre-clinical, clinical, regulatory approval, product launch, and post-marketing monitoring.
Product Development and Engineering:
MasterControl’s product lifecycle management solution automates management of voluminous product spec iterations. It allows the engineering team to work in CAD environments so they can comply with regulations without hampering their development work.
MasterControl provides a PLM solution that equips the quality team with robust tools for managing and streamlining critical quality processes such as CAPA, complaints, and audits. MasterControl’s key advantage over other product lifecycle management solutions is its analytics and reporting feature for tracking and trending quality metrics.
Manufacturing and Operations:
MasterControl’s product lifecycle management solution provides connectivity among all the departments, allowing the manufacturing and operations team to provide input earlier in the product development process. Such collaboration will help in the effort to reduce manufacturing costs and find the best suppliers earlier.
With MasterControl’s PLM solution, the regulatory team can streamline the process for preparing regulatory submissions by making it easier for cross-functional teams to collaborate and provide input in all critical documents.
MasterControl’s product lifecycle management solution provides a single place for storing product specifications and approved vendor information. The purchasing team will readily see changes in documents and processes, so purchasing decisions are based on the latest data and information.
For more information about product lifecycle management (PLM) solutions, or the PLM software from MasterControl, please feel free to contact a MasterControl representative.