Medical Devices are subject to an ever-increasing number of standards, like ISO 13485. Ensuring their quality, safety and efficacy requires a tailored Quality Management System. QbD offers a wide range of solutions to make sure the production and validation of Medical Devices are on the right track from day one.
A basic generic Medical Device lifecycle includes design and development, production, supply, use and maintenance and end of life (disposal). Overall, several key factors need to be taken into account:
- The lifecycle should be versatile enough to apply to all types of Medical Devices that your company wants to create.
- Ensure that the definitions for the research and development phases meet the required controls for a specific product, as defined by the regulations.
- Make sure that the design of the Medical Devices and all changes / updates are clearly defined and documented.
- Perform a clear transfer from the development to the production departments and include all associated documentation.
- Be sure there is a process built into the lifecycle to review your products and verify that they meet regulations and patients’ needs.
- Ensure a robust post-market surveillance process to safeguard your patients.
- Design a process around its End of Life. From a regulatory perspective, no product really ‘ends’: it gets archived and stored, so that the design history is retrievable.
Facing numerous challenges
The production and validation of Medical Devices entail countless challenges, depending on various factors – from the type of device to the company’s size, the market situation and more. These are some of the most determining elements:
- Increased clinical and regulatory standards, like ISO 13485.
- Increased complexity of medical equipment/devices, which results in more difficult production and validation processes.
- More demanding customers, who have more choices nowadays.
- Increased competition from start-ups and spin-offs reduces the profit margin for manufacturers.
- Security of connected medical devices, including wearables.
Lifecycle of Medical Devices
The lifespan of Medical Devices is cyclical, not linear. As a first step, the Medical Device is the result of design and development. Next, it goes into production, taking into account all related documentation. Subsequently, the device becomes part of the supply chain. Finally, it is subject to usage, maintenance or disposal. The insights from the latter phase can be used for design & development, starting up the life cycle again.
Future-proof investment for startups
A Quality Management System based on ISO 13485 is the best guarantee for quality, safety and efficacy of Medical Devices. As a startup, putting a QMS in place might however be the last thing on your mind. You’re more worried about R&D, product and supply chain, and market approval. But the regulations will come to you, and you don’t want to get caught off-guard, so it’s better to invest in the development of a quality system from day one.
Committing assets to compliance is therefore a future-proof investment for startups. Already during the development phase, they should focus on design controls, risk management, document control and supplier management.
Scalable QMS solutions
When establishing a QMS, make sure it suits your company’s size and expected growth. Furthermore, it should be something that the current staff can manage and maintain. Companies with Quality Management Systems that are too large – and thus cannot comply with their own system – set themselves up for failure. Moreover, implementing and maintaining a QMS is a crucial part of regulatory compliance. Quality systems for Medical Devices are primarily concerned with production and post-production.
Although it’s time-consuming, establishing a total QMS doesn’t need to be as challenging as it sounds. The key is to build the system as you develop, focusing on the relevant aspects of quality and ignoring the others until they’re needed. You need to find something scalable. A QMS must support your way of working and be adjusted to it – not the other way around. QbD can help you with a solution that starts off small-scaled and simple, and that grows with your business.
Complying with regulations
Medical Devices need to comply with an increasing amount of regulations. Before 2017, these were still considered to be directives
- 93/42/EEC Medical device
- 90/385/EEC Implantable Medical device
- 98/79/EC In vitro diagnostic medical devices
However, from April 2017, those directives became regulations:
- EU 2017/745 Medical Device Regulation
- EU 2017/746 In Vitro Medical Device Regulation
- FDA 21 CFR Part 820 defines the quality regulations for the U.S. market
Eager to know how we make a difference for the quality management of your Medical Devices activities?