Medical Device Software

Software Compliance and V&V for FDA & ISO

(including device, production, automated processes, mobile Apps, SaMD/SiMD, Cyber Security, AGILE updates, etc.)

(On-site or Virtual Private Group/Company Training)

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Date: Your Choice

Location: On-site or Virtual

Who: Your entire company, department, project team, you select

Overview:
FDA & International regulatory scrutiny of software has become increasingly more sophisticated and in-depth. Devices and manufacturing processes automated with software gain considerable attention during submission reviews and manufacturing inspections. FDA requests for additional software information and documentation are frequent during 510(k) submission reviews and inspections. In fact, FDA's Software Guidance documents for Reviewer's Guidance, Validation, Cybersecurity and OTS (Off-the-shelf) Software significantly impact manufacturers! This course will help to understand how to comply to current regulations and how to prepare for future regulatory requirements & guidance both in the U.S. and internationally. You will receive the latest information regarding FDA regulations and guidance for software including device software, automated process software, mobile medical applications (Apps), cybersecurity, etc. Important international software standards and guidance will be discussed including IEC 62304, TIR 45 AGILE Practices. In addition to device software, discussion will include manufacturing process and test related software of any type of medical device, including disposables & as applicable to pharmaceuticals. This course is important in preparation for FDA & ISO Manufacturing and Design Control inspections; as well as, 510(k), IDE, PMA submissions or CE Mark approvals. Software SOP templates and Checklists applicable to auditing software will be presented. The course includes presentation of Software V&V process planning strategies using a risk-based approach consistent with ISO 14971 concepts for application of risk management to medical devices.

What you will learn:

Benefits of Attending:

Abbreviated Outline:

Instructor(s): To be determined based on schedule and your specific needs. All instructors are very experienced and experts in the field being taught. Biographies will be provided and a discussion with the instructor(s) will be arranged so that a proposal can be provided for training that meets your needs.

Duration: Standard course is approximately 8 hours. Customized courses can vary. On-site courses are typically taught in 1 day. Virtual courses can be taught over multiple days, e.g. 2 days for 4 hours/day, etc.

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