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.
Revised European guidance document on medical device stand-alone software issued
30 August 2016
The European Commission has published a slightly revised version of the guidance document on medical device stand-alone software, MEDDEV 2.1/6, under the current three device directives (AIMDD: 90/385/EEC; MDD: 93/42/EEC and IVDDD: 98/79/EC).
The main differences from the previous version are the inclusion of definitions for 'software', 'input data' and 'output data', and also 'Software as a Medical Device' (SaMD).
Many stakeholders were anticipating a section devoted to mobile apps, but the new guidance does not touch on this subject, other than to state in the 'Introduction' that "The criteria specified in this document apply also to mobile applications."
In parallel, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on the same subject, replacing the document issued two years previously. The new guidance is published in the form of an interactive pdf that developers can use to determine whether their apps are devices, and if so, what processes they should follow to attain the CE mark.
FDA issues two new final guidance documents
27 August 2016
The US Food and drug Administration has announced the availability of two important new guidance documents, these being:
FDA explains that the first guidance has been issued "to ensure consistency with the terminology and concepts used in the Benefit-Risk worksheet that FDA staff utilises to guide benefit-risk determinations of PMAs and de novo requests". FDA will host a webinar on Tuesday, September 27, 2016, with information about how to participate in the webinar being available closer to the date on CDRH’s webinar webpage.
The second guidance is part of the Agency's 'Partner with Patients CDRH 2016-2017 Strategic Priority', explaining that "Patient preference information can provide a unique and important perspective that can help the FDA evaluate the benefits and risks of certain medical devices. This final guidance encourages medical device manufacturers to voluntarily include in their premarket submissions information about the tradeoffs patients may consider when evaluating the benefits and risks of a treatment option."
The guidance outlines:
Recommendations on patient preference studies that may result in valid scientific evidence and how stakeholders, including industry and patient advocacy organizations, can voluntarily collect and submit to FDA patient preference information.
How the FDA includes patient preference information in FDA’s decision summaries that explain what information the FDA relied on in its approval or marketing authorization of the product.
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