We have helped life science companies enter the European and US markets, meet postmarket requirements, and maintain compliance pragmatically and effectively.
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 with 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.
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
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.
ABHI surveys members on 'Brexit' - large majority for remaining in EU
24 May 2016
The UK device industry Association of British Healthcare Industries (ABHI) recently surveyed its members to gauge opinion on the upcoming EU Referendum on whether the UK should leave the EU or remain in the EU. 76 members (around one third of membership) responded, with the following results:
72% of respondents thought that remaining in would be beneficial to the UK as a whole.
51% of respondents had an established position, and for all but one, this position was for the UK to remain within the EU.
None of those without an official position believed it was in their best interest to exit the EU. 61% believed UK should remain and 28% were unsure.
A small number indicated that they believed the result would make no difference to either themselves or the national economy (11% and 3% respectively).
The main reason members gave for Britain to remain within the EU was the uncertainty associated with an exit. Other concerns included:
Currency instability - the potential weakening of the pound against both the Dollar and the Euro leading to rises in costs of raw materials, manufacturing and a reduction in the value of sales.
Possible regulatory divergence in a highly regulated sector. Companies believed that Britain’s influence in the development of the regulatory environment had been positive and an exit would mean both the loss of this influence and the duplication of approval processes for the UK and EU markets.
Impact on UK investment decisions. In particular multinational companies, who may cease to see Britain as the obvious gateway into Europe.
There was a belief that whatever the outcome of the Referendum, what happens within Europe will still have very considerable influence on Britain and her competitiveness. There was, therefore, a very strong consensus that the interests of the sector, and the country as a whole, are best served by Britain being at the heart of European decision making as an EU member.
FDA issues final order on EPPG and PSA devices
18 April 2016
The US Food and Drug Administration (FDA) has issued a 'final order'in the Federal Register to reclassify external pacemaker pulse generator (EPPG) devices, which are currently preamendments class III devices (regulated under product code DTE), into class II (special controls) and to reclassify pacing system analyzers (PSAs) into class II (special controls), and will in future be subject to clearance under the premarket notification (510(k)) program.
This final order also creates a separate classification regulation for PSAs and places single and dual chamber PSAs, which are currently classified with EPPG devices, and triple chamber PSAs (TCPSAs), which are currently postamendments class III devices, into that new classification regulation.
Following the effective date of this final order, 18 April 2016, firms marketing an EPPG or PSA device must comply with the applicable mitigation measures identified in the special controls. Manufacturers of EPPG or PSA devices that have not been legally marketed prior to the effective date, or models (if any) that have been marketed but are required to submit a new 510(k) because the device is about to be significantly changed or modified, must obtain 510(k) clearance and demonstrate compliance with the special controls included in this final order, before marketing the new or changed device.