The medical devices industry is evolving rapidly, with new technologies and applications emerging alongside a growing focus on automation from established manufacturers
Risk identification and management are essential for successful certification by the FDA, Health Canada, and other bodies.
Guided by
What we offer ?
Client Centric
Client-focused approach
Tailored solutions
Gap Analysis and Certification Support
End to End Support
From training to risk assessments
FMEA and Risk Control Measures
Software Certification
Proficient
ISO 14971
IEC 62366, IEC 62304
Assessment of (SOUP) Software of Unknown Provenance
What sets us apart?
We have extensive experience and a thorough understanding of ISO 14971, particularly in the definitive risk identification and risk assessment procedures for medical devices.
Applying ISO 14971 process in certification of radiotherapy machines for Oncology Treatment
Using FMEA for risk reduction & identification of risk control measures (RCM)
Support usability analysis following IEC 62366
Support IEC 62304 software lifecycle process implementation
Assessment of SOUP (Software of Unknown Provenance)
