We have helped life science companies enter the European and US markets, meet postmarket requirements, and maintain compliance pragmatically and effectively.
GAP ANALYSIS FOR CLINICAL STUDIES
Is your company experiencing problems with your clinical study, such as enrolment issues or significant delays in study start? Our clinical gap analysis will help you understand the problems and implement solutions. Learn more.
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.
MHRA consults on reuse of single use devices (SUDs)
23 July 2015
With the likelihood that the revised medical device regulations will include requirements for the 'remanufacture' of many medical devices that have been designated as being for single use only by their manufacturers, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has decided to consult on a draft guidance document now available from the Agency, according to a press release.
The draft, titled 'Single-use medical devices: UK guidance on re-manufacturing', is available from here, and comments will be accepted until 1 September 2015.
IMDRF consults on the Regulated Product Submission (RPS)
21 July 2015
The International Medical Device Regulators Forum (IMDRF) has published on its website a draft document related to the potential future standardization of medical device regulatory data, titled 'Common Data Elements for Medical Device Identification', together with a form for submitting comments.
IMDRF explains that "In future postmarket activities, a Unique Device Identification (UDI) system is expected to capture the device identification data elements at the level of a particular device. However, at the point of pre-market submission, specific device identification data elements are not always clearly specified. Therefore it would be useful to establish common data elements, for which values can be provided in the premarket processes and used throughout the lifecycle."
The draft continues "This document outlines the common data elements for medical device identification that may be used through regulatory activities or process (pre-market, and post-market), including the future possibility of electronic regulatory submission of device identification information. This document will cover the harmonization of terms and their definitions– i.e., the focus is on definition."
Comments of the draft will be accepted until 15 September 2015.