COURSE / module Detail


Software Development for Medical Device Manufacturers -

Description: This comprehensive 4 hour online course provides practical guidance and suggestions for developing software that complies with applicable FDA and EU regulations, FDA Guidance documents and international standards such as IEC 62304 and ISO 14971. Focus of this course is interpreting FDA Design Controls for software. Each section of the Design Controls regulation (21 CFR Part 820.30) is discussed from the software perspective. Corresponding requirements from IEC 62304 are woven into the discussion

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Cost: $220.00

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