profilePage

Bringing a wealth of knowledge and resources to small and mid-sized medical device companies:

Scalable: Training, Systems, Solutions for ISO 13485 compliant Quality Management Systems. (Leveraging proven SOPs, Customization, Training, Implementation): Doc Control, Design Control, Supplier Evaluation, IQ/OQ/PQ, Maintenance & Calibration, Receiving/Inspection, Nonconforming Material, Complaints/MDR/Vigilance Reporting, CAPA, Management Review, Internal Auditing, process development, process validation.

Facilitate or Train for ISO 14971:2012 Risk Management Systems (Hazard Analysis/Risk Assessment/FMECA) to maximize value added through early concern identification.

Full Regulatory Assessm...

�ݺ�ߣ