Your CRO partner for successful management of clinical studies in Europe, US and Canada for medical devices, IVDs and combination products.
A trusted resource for US and EU medical device regulatory and quality system requirements also providing EU Authorized Representative and US Agent services.
In Vitro Diagnostics
In Vitro Diagnostics
IVDs have distinct requirements in both the US and Europe. We have the IVD regulatory, quality system and clinical study expertise needed for US and European market entry.
Helping companies understand the important differences between US and European requirements for drug-device combination products and drug delivery devices.
FDA releases quality system inspection results for 2013
30 September 2014
The US Food and Drug Administration (FDA) has made available a summary of the results of its quality system inspection program for 2013, providing information on both inspectional observations and warning letters.
The headline figures are:
3% reduction in total number of device manufacturer inspections
Domestic (US) inspection number reduced by 6%
Foreign inspection number increased by 17%
17% increase in the total number of inspectional observations
No change in the top three subjects for inspectional observations: CAPA, Complaint Files, Quality Audits
144 warning letters issued, down 12% on 2012
4% of domestic firms received warning letters
16% of foreign firms received warning letters
A copy of the results presentation can be obtained from here.
MHRA issues Safety Alert regarding delays in reacting to FSNs
29 September 2014
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a 'Medical Device Alert' to all hospital in the UK to advise that more attention should be paid to actions resulting from the issuance of Field Safety Notices (FSNs) by medical device manufacturers.
The Agency explains that an FSN is a communication sent by medical device manufacturers, or their representatives, in connection with a Field Safety Corrective Action (FSCA). FSNs outline actions to be taken by user organisations to reduce the risk of death or serious injury associated with the use of a medical device.
The Device Alert continues by stating: "It is very important that your organisation takes the actions detailed in the FSN and replies to the manufacturer, acknowledging receipt of the FSN. Your organisation's reply is the evidence that the manufacturer, and subsequently the MHRA, needs to monitor the progress of the FSCA. Without this reply the manufacturer cannot properly verify if the FSCA is complete and so the MHRA may need to issue advice. Your organisation could be liable if it does not act on safety information provided by the manufacturer and something goes wrong as a result."
A copy of the Device Alert can be accessed from here.