We have helped life science companies enter the European and US markets, meet postmarket requirements, and maintain compliance pragmatically and effectively.
Your CRO partner for successful management of clinical studies in Europe, US, Canada and Israel 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 issues final guidance on sex-specific data in clinical studies
21 August 2014
The US Food and Drug Administration (FDA) has posted a final guidance document, “Evaluation of Sex-Specific Data in Medical Device Clinical Studies” outlining specific recommendations for considering sex and other variables during the design stage of a clinical study, to improve consistency of analysis and reporting of information on demographics in labeling and other public documents.
The agency comments that certain medical products may elicit different responses in women than men and these variables may affect the safe and effective use of the device. FDA will hold a webinar on 25 August 2014 at 15:00 Eastern Time to explain the guidance and to provide an opportunity to ask questions.
TGA targets 8 Notified Bodies for increased audit activity
20 August 2014
The Australian Therapeutic Goods Administration has announced that it will be selectively auditing all applications for inclusion of medical devices in the Australian Register of Therapeutic Goods (ARTG) that use supporting evidence from eight named notified bodies. The announcement follows investigations after publicaion of the October 2012 British Medical Journal, which included an article titled 'How a fake hip showed up failings in the European device regulation' (BMJ 2012; 345: e7126). The TGA comments that it is "conducting these application audits to obtain its own evidence of the quality of certificates and reports issued by these notified bodies".
The notified bodies concerned are located in the Czech Republic (1), Hungary (2), Slovakia (2), and Turkey (3). The BMJ article questioned whether these notified bodies were "likely to be more interested in repeat business than patient safety". The full list of the notified bodies concerned is available from the TGA website.