Day

June 30, 2021
30
Jun

FDA Recall: Injury Resulting from Exceeding Standard Presets

June 30, 2021
Company: Olympus Corporation of the Americas Date of Enforcement Report: June 30, 2021 Class II PRODUCT Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterological surgery and gynecological...
Read More

SoftwareCPR Training Courses

ISO13485:2016 ISO 13485 Internal Audit(or) Training Course (Live, 3-day)

IEC 62304 and other Emerging Standards Impacting Medical Device Software (Live, 3-day)

Being Agile & Yet CompliantISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
office@softwarecpr.com
Partners located in the US (CA, FL, MA, MN, TX) and Canada.