The CROMSOURCE Medical Device team knows and understands medical device and diagnostics regulations; most of the staff has been through the regulatory process for clinical trial and product approval in the USA and EU many times. Therefore our operational team understands the regulatory implications of its actions and decisions, so your clinical study or regulatory submission is in safe, expert hands. We are also able to offer our clients the benefit of a large collective experience when formulating and implementing regulatory strategies and study designs, and CROMSOURCE’s mid-size and flat management structure means that this experience is not lost within a vast organisation.
Of course, when selecting a partner, you want to know that your project will be delivered as planned – high quality, on time and to the contract price.
CROMSOURCE is unique in GUARANTEEING these deliverables. It is part of the mantra by which we work: Advise Agree Deliver. We freely give our advice to agree the perfect project plan with each client. And then we deliver that plan. As agreed, on time and to budget. Guaranteed. We think that makes us different.
Expand the boxes below to learn more about our services, experience and publications:
- Changes to EU Medical Device Legislation: What you need to know - White Paper June 2016
- Clinical Data for Medical Devices - Preparing for increased requirements in the EU - White Paper, 2015
- Medical Device Overview
- Clinical Evaluation Reports - White Paper, 2015
- Wound Closure - White Paper, 2014
- EU Recast of the Medical Device Directives: The Rocky Road to the new Medical Device Regulation - White Paper, 2014
- Language Requirements for EU Medical Device Labels - Multilingual, September 2012
It is a pleasure to work with CROMSOURCE. I really appreciate the transparency and efficiency in communication. They are committed to the client and consider any project as if it is their own. They are responsive, with a proactive problem-solving attitude. The client’s goal is their own goal! We really feel CROMSOURCE is part of our team!