Regulatory requirements need not be overly burdensome if they are complied with efficiently. Efficiency makes a large difference to both large and small businesses. Syprosoft Engineering is able to drill down to the principles underlying the regulations and interpret the text of the regulatory language in a customized manner to design efficient systems for its clients that minimize the regulatory burden. We can help audit existing processes and recommend improvements that will help the client’s operations.One way to minimize regulatory burdens is to use a risk based approach. Syprosoft Engineering has extensive experience with the risk management process and follows the ISO 14971 standard - Application of Risk Management to Medical Devices. In accordance with this standard, we have helped our clients prepare and update their risk analyses by using both production and post-production data, and data from published literature.
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