Medical device companies are responsible for the safety and effectiveness of their products throughout the entire medical device life cycle, creating a need for rigorous pre-market trials and post market surveillance activities to monitor the performance of medical devices.
The effective management of medical devices throughout the medical device life cycle is a crucial process that provides value for the manufacturer and the end user. As medical devices transition through each stage of their life cycle, they are subject to new types of processes, testing and regulatory requirements.
Medical device regulators in the past have focused quality regulations on the device design and development process, but more recently, updates to medical device standards such as ISO 13485:2016 have seen the inclusion of additional post market requirements, reflecting an added emphasis on full-life cycle management of medical devices.
What are the Stages of the Medical Device Life Cycle?
The concept of a life cycle for medical devices is adopted from the broader idea of a product life cycle (PLC). Like all products, medical devices begin their lives in a manufacturing plant, then sold to the end user and may be used until the natural end of their life cycle.
The life cycle of a medical device can be divided into six distinct parts, with unique regulatory requirements that apply in each phase:
1. Concept: In the concept phase, the medical device exists only as an idea. Each medical device begins as an idea for solving a medical problem that someone has in an easier, cheaper or more effective way. In the concept stage, a medical device developer may begin to initially define the product, explore funding options and potential routes to market and begin to establish early requirements for the device.
2. Planning: The planning stage for medical devices is characterized by the collection of user needs and the translation of those needs into technical requirements for the final product. Here, engineers may start building prototypes, establishing a regulatory strategy, classifying the risk of the device, building a design file and broadening the project plan to market the device.
3. Design: Once requirements have been established the medical device enters the design phase. Here, engineers will iterate on the product design, collect feedback from users, perform design verification and validation and begin to draft technical documentation. The product may be ready for brand development, and it could also be time to start developing a manufacturing process that will enable mass production.
4. Validation: In the validation phase of the product life cycle, medical device companies conduct clinical validation activities to verify that the device is safe and effective. The product will be labeled and regulatory submissions will be made so that the product can be marketed in the desired areas.
5. Launch: Once a medical device company gains approval to market a medical device, the product enters the launch phase of its life cycle. The product will be sold to healthcare providers, hospitals and clinics, and the manufacturer will provide training and support that enables effective use of the product.
6. Post Market: Once a medical device has entered the marketplace, it also enters the post-market stage of its life cycle. Post market surveillance activities will be conducted to ensure that adverse events that involve the medical device are reported, clinical follow-up studies may be conducted and the manufacturer can still address complaints or adverse events and make improvements to the product. If the product is successful, it may be launched into new markets.
Greenlight Guru Supports Quality Throughout the Medical Device Life Cycle
Greenlight Guru's eQMS Software offers medical device companies an integrated framework for managing quality throughout the medical device life cycle that is compliant out-of-the-box with the FDA QSR and ISO 13485:2016 standards.
With Greenlight Guru, medical device companies can establish user needs, link those needs to technical requirements and design inputs and outputs, relate those design features to device risk, and even manage customer complaints and CAPA events as part of their post market surveillance.
Greenlight Guru’s Quality Management Software Platform creates a single source of truth, leveraging cloud storage to securely store quality documentation and giving medical device companies strong visibility into their internal processes throughout the entire medical device life cycle.