ISO 13485 is a global standard for quality management and assurance in medical devices. In previous posts, we have discussed the basis of the standard and its comprehensive nature. Because of its rigorous detail, it empowers organizations to adapt to the many serious challenges of preparing their devices for commercialization and executing according to the highest regulatory expectations.
Production is the second step covered by the ISO 13485 standard. It encompasses everything related to medical device manufacture. Although many enterprises outsource production to a partner, ISO 13485 assumes all activities in the production process fall under the same quality regime. This simplifies and streamlines oversight while ensuring end-to-end quality.
Medical Device Production: Challenges and Opportunities
The design and development phase transmutes R&D findings into practical realities in terms of safety, quality, and customer-facing deliverables. When this phase has been completed, verified, and validated, production of the finalized device can begin in earnest.
Production typically begins with a small batch of devices subjected to testing under “simulated real world” conditions. Such prototypes should be thoroughly examined to ensure there are no unexpected responses to mechanical or environmental stress.
Once this initial testing battery is complete, enterprises can harness significant opportunities in the production phase. By leveraging manufacturing best practices and economies of scale, it may be possible to significantly reduce production costs over time.
However, it is crucial not to lose sight of the central importance of quality.
A single production defect can have life-altering repercussions for a patient. Likewise, should an entire batch be affected by a defect, it can result in a class action lawsuit with devastating financial and public relations consequences.
Outlining ISO 13485 Medical Device Production Standards
ISO 13485 protects the organization and consumer by establishing clear standards for controlled conditions in production. Controlled conditions can include all of the following, as applicable:
- Availability of information resources describing the product’s characteristics;
- Availability of documented procedures, requirements, work instructions, and references;
- The use of suitable equipment during each step in the production process;
- The availability and use of monitoring and measuring devices as needed;
- The implementation of monitoring and measuring to ensure device quality;
- Definition and implementation of release, delivery, and post-delivery activities;
- Implementation of defined operations for labeling and packaging products.
These requirements, conceived broadly, deliver high standards of quality management when a device – either individually or as a batch – is under the manufacturer’s control. However, it is also necessary to establish records with long-term traceability for each batch of devices. The documents should specify the amount manufactured and the amount approved for distribution.
In a sense, production can be considered the heart of the ISO 13485 quality management system, since it emphasizes the procedures needed to minimize production problems. Should a quality exception occur, the documentary standards are in place to help identify and correct the root cause quickly.
ISO 13485 defines detailed approaches for measurement, monitoring, and continuous process improvement. This includes internal auditing practices that look at such matters as appropriate controls for nonconforming products and analysis of production data. Corrective and preventive actions are combined, encouraging organizations to behave proactively.
Sound Production is Essential for Compliance, Quality, and Commercial Success
Most enterprises spend the majority of their operational time and resources managing the production process. Stakeholders must clearly understand and capably execute their duties in that process, backed by all necessary technology. It is essential that all necessary groundwork be laid from the beginning.
Technosoft Innovations helps its clients craft and execute a fully ISO 13485-compliant system that supports world-class quality excellence from day one.
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