Digitization for the medical device industry
The laws and regulations in the medical industry are strict, vary by country and are designed to ensure the quality and safety of medical devices. As a supplier to the medical sector, you are bound by strict compliance with international regulations. That requires continuous maintenance of your quality processes. We help players in the medical industry accelerate innovation. We design and implement a PLM (Product Lifecycle Management) platform that is specifically designed for processes in medical device development.
As a manufacturer you are obliged to implement a quality management system (QMS). In a QMS you define a series of processes and procedures that you implement to comply with the regulations, including Design Controls. Which regulations these are exactly depends on the market in which you are active. In the US, you follow FDA regulations (21 CFR Part 820). In Europe, a quality system is required according to ISO 13485: 2016 to meet the requirements of the EU.
What are “Design Controls”?
Design Controls is an interconnected system of controls and verifications in the design and development process. When you implement design controls, systematic design review becomes an integral part of your product development. You can correct any shortcomings early in the development process. In addition, you are better prepared for all the administrative requirements that the regulatory authorities impose on you for the approval of a product.
What solution does a PLM system offer?
We have extensive experience in the medical industry and understand how the product development process should be structured to guarantee the safety and effectiveness of a medical device. We set up the PLM system in such a way that we follow the design logic that goes with the development of your products and that immediately meets the requirements set by the FDA.
Below is an example of design checks that are aligned with the guidelines:
User Needs are recorded, risks are identified, resulting in Design Input requirement specifications. The Design Inputs drive the product and production process design activities, resulting in Design Outputs in the form of design specifications such as 3d models, drawings and specifications.
The Design Outputs are verified, the device itself and manufacturing processes are validated.
This will be completed by Design Transfer, for volume production and eventual service and support of healthcare devices.
Important records must be kept throughout the life cycle:
- De Design History File (DHF); a compilation of documentation describing the design history of a finished medical device
- De Device Master Record (DMR); a compilation of all instructions, drawings and other records that must be used to produce a product
- De Device History Record (DHR); a compilation of all production instructions, bills of materials, acceptance records and product identifications
What value do we bring to the medical industry?
- Connected systems a requirements-driven quality management system, with integration of your hardware, software and production process development
- Predictable development with maximum traceability. We model the requirements typing and their mutual relationships by means of smart representations and various multidimensional matrices
- Software as a medical device. What if the device is a software-only product? How do you manage the software life cycle and the traceability to the module and hardware components. Traceability of source code and associated tests determine the shortest time-to-market
- Fast implementation through our medical device templates, which are based on the ISO13485 / FDA 820 and part 11
- Compliance management through integrated Verification & Validation. Test cases, planning and execution are an integral part of the requirement engineering process
- DMR in a second, with a single push of a button you can generate the complete Device Master Record (DMR) / Technical File (TF)
Digitization, Realization and Simulation
To stay ahead of your competitors, three focus points will set you apart from the other players;
- Digitization: automating data exchange and data-driven approach from one central source
- Realization: Good ideas have little value until you convert them into “realized” devices that perform safely and effectively in the healthcare value chain
- Simulation: A digital twin predicts how your products will perform during manufacture and in the field. You optimize production and service activities before they actually occur
Our proven solutions are built on the above improvements and ensure device quality, traceability and regulatory compliance throughout its lifecycle. Do you want to know more? Then contact us and let us inform you what we can do for your company.