Regulatory Approvals
Our work with large companies, medical companies, and companies that wish to sell overseas has given us experience in designing to regulatory standards. We know how to address regulatory requirements early in the design process, thereby avoiding the costly re-engineering that some companies must engage in just to get a product through standards testing.
Product Development
In North America, companies often comply with UL/CSA standards. In addition, medical devices need to comply with standards so they can present that compliance to the FDA. Even for non-medical devices, a product must conform to the appropriate standards in order to be sold in the European Union.
For example, even though your product may not be a medical product, you still must consider FCC regulations in order to sell in the US, and EU device directives in order to sell in Europe. While there are all sorts of standards to consider, one that applies to many products is the IEC60950 International Safety Standard for Information Technology Equipment.
For medical product design in the United States, the quality system is governed by the Code of Federal Regulations (CFR) Title 21 part 820. In particular, sections 820.30 (Design Controls) and 820.40 (Document Controls) pertain to the design and development process. BCA’s design process for medical devices conforms to these regulatory requirements. Any abbreviations in the extent of the process for medical devices must be justified by the Level of Concern of the device (i.e. safety / risk assessment). BCA’s Quality System Design process also complies with the international standard ANSI/AAMI/ISO 13485: 2003 Quality Management Systems - Medical Devices - System Requirements for Regulatory Purposes.
Medical products must meet the IEC 60601-1 Medical Electrical Equipment standard. In addition, there are “particular” standards that go over and above IEC 60601-1 for specific types of medical devices. For example, we have recently been working with IEC60601-1-18 Particular Requirements for the Safety of Endoscopic Equipment. Collateral standards are also applicable to all medical devices, such as the IEC 60601-1-2 Electromagnetic Compatibility standard.
The newest version of IEC60601-1 requires that a risk analysis be performed using ISO 14971 Application of Risk Management to Medical Devices. We have developed a template to perform an ISO 14971-compliant risk analysis and have used it successfully for several devices.
In the United States, the documentation that must be submitted to the FDA for a medical product is dependent on the Level of Concern of the device. The Level of Concern is based on the severity of human injury should the device malfunction. The FDA maintains an informative website at www.fda.gov. This site provides many documents to help medical device start-up companies learn what type of documentation is necessary for 510(k) submission. In particular, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices is a must-read for those interested in 510(k) submissions.
Medical Manufacturing
Although the Medical Device Regulatory Quality Standard (ISO13485) is oriented towards medical device manufacturing, it does require that certain methodologies be followed in the design process. We have reviewed our process in light of this standard — our process provides a fine complement to the manufacturing processes you have in place to allow ISO13485 compliance.