Five FDA officials answer questions from medical device manufacturers about the agency’s Quality Management System Regulation, or QMSR, which goes into force for industry on
The FDAâs new Quality Management System Regulation, effective Feb. 2, will allow the agency to review a medical device manufacturer’s internal and supplier audit findings
An effective CAPA system is critical for MedTech manufacturers to meet FDA and ISO requirements and avoid costly compliance failures. This article outlines five expert
Effective management control is essential for medical device companies, as FDA views executive leadership as ultimately responsible for quality system performance and many deficiencies stem
The FDAâs recent warning letter to a wearable technology company signals that the agency may heighten scrutiny of devices offering features such as blood-pressure estimation
Successful document control in medical device and pharmaceutical companies hinges on understanding the audience and involving all relevant stakeholders in document creation and review. Maintaining
Effective root cause teams in medical and pharmaceutical industries are made up of volunteers who are motivated and have relevant expertise, not just the smartest
A MedTech expert emphasizes the critical role of technical writers in ensuring clear, compliant documentation, cautioning against the use of emojis in official quality system
The FDA urges medical device makers to prepare now for the new Quality Management System Regulation. Though similar to ISO 13485, compliance requires active effort.
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