The dilemma of reporting device-related adverse events.
One of the most difficult decisions that medical device companies may face is whether or not to report an adverse event to regulatory authorities. This article discusses a series of UK vigilance guidance documents for device implants designed to assist manufacturers in making these decisions and the wider value to industry that these documents may have.
Donawa
Maria
M
donawa@srd.it
D030881:Disclosure / Q000592:standards*; D004868:Equipment Failure; D004869:Equipment Safety / Q000379:methods / Q000592:standards*; D005060:Europe; D019221:Mandatory Reporting; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000592:standards*; D019736:Prostheses and Implants / Q000009:adverse effects / Q000592:standards*; D011475:Prosthesis Failure; D012308:Risk Management / Q000379:methods / Q000592:standards*; D006113:United Kingdom