MDSAP
Medical Device Single Audit Program
Single QMS audit recognised by five regulators — FDA (US), Health Canada, ANVISA (Brazil), TGA (Australia), PMDA (Japan). One audit instead of five.
MDSAP allows a recognised Auditing Organisation to conduct a single audit of a manufacturer's QMS that satisfies five regulators. Mandatory for Canadian market access; voluntary but cost-saving elsewhere. Audited to ISO 13485 plus jurisdiction-specific requirements (e.g. 21 CFR 820 for US).
V5's medical-device profile is designed to map cleanly to MDSAP audit tasks: process audits (mgmt, measurement/analysis/improvement, design & development, production & service controls, purchasing, device marketing/registration/listing/UDI, medical-device events).
Free trial, no credit card, onboard in days, not months.