Improve the visibility and traceability of your data and get ready for EU MDR
Medical device companies put a lot of emphasis on quality. That is why most companies have invested in best practice processes together with one or more quality-related systems.
The challenge with this approach is that there is no closed loop from the Quality System to the DMR which results in a lot of manual processes across every phase of the device life cycle.
Manual processes can inhibit good product design and quality because development processes lack integration. Each department has its own distinct systems to support it needs and this is exacerbated as oftentimes they work in functional silos. Manufacturers need solutions that not only archive and manage data, but also facilitate the sharing of product and process data within the company, as well as with suppliers and partners.
By having all information in one solution, the visibility improves across the entire organization including the supply chain partners.
Medical Device PLM provide technology-enabled processes to ensure proactive quality assurance which increases overall efficiency, minimize risks and enhance product innovation.
With our digitalized, integrated solution, globally diverse companies can identify and resolve quality issues at the earliest possible stage. By embedding and utilizing analytical data throughout the product life cycle, medical device companies can support higher production rates, reduce cost of goods, and achieve more efficient regulatory-mandated control processes. Also, the likelihood of adverse events or product recalls can be dramatically reduced, if not eliminated entirely.
Medical Device PLM provides a system that identifies and improves areas resulting in time-to-market inefficiency, products not meeting regulation specifications and inaccurate information flow.
- Reduce risk by exposing potential quality issues and defects before product release
- Increase efficiency when reacting to quality issues when they occur and drive product changes to remove future quality escapes.
- Manage compliance from product design through to product delivery
- Save money, improve product quality, and meet customer requirements by integrating quality management with product development and process planning
- Streamline quality management and improve the productivity of quality management personnel by maintaining consistent quality processes across products and in the supply chain
Medical Device PLM In Depth:
Medical device product development is a highly integrated and regulated process. Implementation of solution-based requirements tracking requires attention to a variety of nuanced topics.
As product complexity increases and companies become more reliant on their supply chains, managing the change process and communicating change status across many groups inside the organization and into the supply chain is an increasing challenge.
Ineffective or poorly managed change processes can leave medical device companies struggling to improve quality, reduce time-to-market and manage costs.
Medical Device PLM allows engineers to have all relevant information available as the change is executed. This makes the analysis phase of the change much easier, less time consuming, and more reliable. All the product data and documentation will automatically be updated when the change is released, making new data instantly available and without any manual updates.
- Improves ECO cycle times
- Reduces errors, delays, scrap and rework
- Improves product quality and reduces cost
- Avoids delays in product launch
- Faster response to customer requirements
- Improves customer service
During the lifecycle of a typical product many documents are created containing critical information which needs to be shared. The creators and users of these documents are usually spread across many functions and locations making the management of these documents a significant challenge.
- Easy access to critical documents reduces unnecessary errors and delays
- Secure online collaboration supports global product development and supply chain collaboration strategies
- User authentication and access management increases control over critical intellectual property
- Ability to include documents in all PLM processes increases engineering efficiencies