Risk Management & Other Services

Supporting Every Aspect of Producing Safe and Effective Products That Meet Customer Needs

60601-1; 2005 (Edition 3) Compliance Upgrade Package: Within the next 3-4 years, it will be necessary to upgrade electrically operated medical devices to the new edition of 60601-1. This could become an overwhelming burden on already stretched Engineering resources.

Rather than wait until the deadline to comply with the new IEC/EN 60601-1 is close, let SDCS provide detailed compliance gap analyses (by experts who wrote the new standard) and generate the documentation required to comply with the new standard. Our 60601-1 Compliance Upgrade Package allows your Engineering Staff to focus on new designs because our experts are assuring that current production will comply with the new version of IEC/EN 60601-1 and the required collateral standards..

Whether you need support in understanding or applying medical device and process standards, SDCS is your one stop supplier of training, engineering and compliance support!

Risk Management Compliance Analyses: Implementation of a risk management process has become a critical element of meeting both regulatory and standards requirements. We have been involved in the writing of the currently accepted benchmark for Risk Management ISO 14971 allowing us to help you assure the compliance of your process. Our articles on elements of this process have been distributed in publications such as MDDI.

Market Development: Hearing the voice of your customer is pivotal to a successful product launch. Our extensive contacts around the world can help achieve a comprehensive understanding of the needs and wants of potential customers in virtually all markets. We can then help your development teams create a concise and accurate list of design inputs that will ensure success.

Other Services: Our expertise can provide crucial support to assure that unwanted surprises don't occur due to the acquisition of products or organizations. We offer experienced consultation and guidance to small companies in licensing or selling products they have developed to large organizations. Our expertise allows us to act as impartial experts in device safety during litigation and help focus the discovery process on the most important documentation.

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