Effective risk management programmes.
Far too many medical device companies are failing to reap the benefits of an effective risk management programme. Thus, patients, users and the companies themselves are continuing to suffer the consequences of device problems that could have been identified and resolved before products are placed on the market. This article discusses how to implement an effective programme.
Donawa
Maria
M
Donawa & Associates Ltd, Rome, Italy. donawa@srd.it
D018795:Device Approval / Q000592:standards; D030881:Disclosure / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005062:European Union; D017408:Guidelines as Topic; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000379:methods* / Q000458:organization & administration* / Q000592:standards; D012308:Risk Management / Q000379:methods* / Q000458:organization & administration* / Q000592:standards; D006113:United Kingdom