QualityHub regulatory expert Rebecca Fuller will lead key sessions at KENX’s MedTech and GMP University, offering practical guidance on risk management, DHFs, post-market surveillance, and
Life sciences companies regulated by the FDA and other authorities must conduct audits to ensure compliance, evaluate quality systems, and mitigate risks to product safety
The EU MDR requires manufacturers to develop and maintain comprehensive technical files that demonstrate a medical device’s compliance with safety, performance, and post-market surveillance requirements.
A leading medical device manufacturer faced costly penalties from an unresolved FDA consent decree due to unaddressed product issues across 50 failure modes. QualityHub’s comprehensive
A global biotechnology leader partnered with QualityHub to conduct thorough third-party audits across its facilities, suppliers, and R&D sites, ensuring rigorous compliance and risk management.
Conducting effective remote audits require a good deal of organization both before and during the audit to ensure adequate preparation of the audit team, effective
QReview is QualityHub’s flexible, on-demand remote consulting and document review service, providing clients with rapid access to expert guidance across quality, regulatory, and validation challenges.