We have helped life science companies enter the European and US markets, meet postmarket requirements, and maintain compliance pragmatically and effecti vely.
ISO TC 194, Working Group 4
is responsible for the development and revision of the international standard on medical device clinical studies. Dr. Maria E. Donawa, President, DLC, an active member of the working group, will participate in the next meeting, which will be held in Washington, D.C. on 21-22 September 2016.
Service Highlight: US and Serbia!
We are happy to announce the appointment of Ana-Maria Panaitoiu, M.D. as US Clinical Services Coordinator and Predrag Vasiljević, M.D, as Senior CRA for Serbia.
Ana-Maria brings to the DLC team extensive experience in the management and monitoring of US and Canadian clinical studies for medical devices and IVDs, together wit h her expertise in several therapeutic areas.
Predrag will allow DLC clients to benefit from qualified monitoring and site selection services in Serbia as well as in other Eastern Europe countries.
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.
New guidance documents from FDA
2 July 2016
Over the last couple of months, the following finals and draft guidance documents have been issued by the US Food and Drug Administration (FDA):
We very much appreciate the kind comments that we have received from our clients. Here are just a few of them.
I can share [with] you that working with Mrs. Karrer and her colleagues is a real pleasure, given their professionalism, knowledge and experience in the field of clinical regulation and research. I am sure you will enjoy their assistance through long term of clinical cooperation between your hospital and [our company].
Israeli medical device company writing about Daniela Karrer, Director, Clinical Affairs and our clinical department