This guide details continuous post-approval compliance in the US and Canada, emphasizing regulatory understanding, pharmacovigilance, surveillance, change control, labeling, adverse event reporting, and license maintenance to safeguard products.
This guide emphasizes continuous post-approval compliance via strong QMS, internal audits, risk management, and mock inspections to ensure FDA and Health Canada readiness, enhancing quality and regulatory trust.
Post-approval compliance in the US and Canada ensures market access, patient safety, and avoids enforcement risks through vigilance, complaint handling, recalls, and strategic planning with expert support.
This guide outlines essential post-approval compliance steps for US and Canadian markets, emphasizing regulatory adherence, pharmacovigilance, adverse event reporting, change control, and recall readiness to ensure product safety and market…
This guide details sustaining FDA and Health Canada compliance post-approval through robust QMS maintenance, CAPA reviews, risk management, supplier qualification, pharmacovigilance, and regular audits to ensure continuous inspection readiness.
Build a compliance-ready QMS by aligning FDA QMSR and ISO 13485 standards using a risk-based approach, a 90-day roadmap, and expert support from Arora 297 Consultancy for efficient regulatory success.
Effective medical device QMS ensures compliance with ISO 13485, FDA QMSR, and Health Canada's MDSAP through documented processes, risk management, CAPA, supplier control, audits, and validation.
Maintain ongoing FDA and Health Canada compliance post-approval through rigorous change control, quality management, regulatory intelligence, post-market surveillance, complaint analysis, recall readiness, and supplier audits.
Post-approval compliance in the US and Canada demands robust risk management, pharmacovigilance, complaint handling, and QMS aligned with FDA and Health Canada standards to ensure audit readiness and product safety.
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