Software continues to be a key factor in recalls, and this year the end of some EUAs may also contribute to an increase.
Across Asia, government health and safety authorities have tightened regulations on medical devices this year, as markets continue to experience rapid change, and as the devices themselves gain sophistication and complexity at a blistering pace.
This new pathway is a considerable change for the medical device industry.
The FDA wants to know that rework activities are not impacting product safety and efficacy issues or influencing long-term product reliability.
When it comes to adverse event reporting, the FDA does not grant exemptions.
Can your company prove its device has been manufactured in accordance with its DMR?
Audits are the cornerstone of a QMS.
You must respond within 15 days, and you must show FDA how your establishment will be brought back to compliance.
The agency has issued its list of the most common inspectional observations for FY 2017.
Simply stated, an inspection needs to add some value; otherwise, what’s the point?