Why Choose MedServe as your Quality, Regulatoy and compliance partner
We are strong team of QRC experts, with technical, quality, regulatory and clinical competence. Our experienced staff and global network will provide the support you need, always. Together, we bring your medical device to the global market, complying with international regulations and assuring product quality and safety. We are cost effective and we charge you for the work performed and no hidden cost.
Our goal is to provide the professionalism that you expect in a partner and to get the results you need in the most efficient and cost-effective manner.
Discover Our Expertise and Services- Our Experience Matters
Clinical Evaluation as per EU MDR
A clinical evaluation takes place in three steps. In step one, manufacturers identify clinical data from existing literature, clinical experience, clinical trials, or any combination of the three. Stage two involves appraising the data's relevance, applicability, quality, and significance. The third step requires you to articulate your conclusions in the CER, based on the data you collected. Approach the CER as a standalone document even though you will include it with your technical file or design dossier. Regular updates to your CER are required as part of your post-market surveillance and vigilance activities. You must record any notable changes that impact the initial data and append the CER accordingly. Failure to do so could jeopardize your conformity with the Medical Devices Directive.
Our Medical Device Experts have successfully delivered several Clinical evaluation reports complying to EUMDR and we are here to support you.
For further discussions, please CONTACT US.
Quality Management System
MedServe will help you to implement adequate and customized processes to comply with global medical device quality management system requirements.
> ISO13485 gap assessments,implementation & Maintenance.
> Internal Audit, Surveillance audit support
> Digital QMS & Doc. Management System
> Defect, CAPA & Customer complaint Tracking system
> Support on SDLC, Usability and product testing
> Online & Classroom training on different Quality & Regulatory subjects/ areas.
Leverage our expertise to support & strengthen your company QMS. CONTACT US
Medical Device Regulatory Services
Our medical device regulatory services include both pre-market and post-market activities, ranging from the compliance, publishing, submission and update of Medical Devices Regulatory files. We utilize years of hands-on experience to ensure our clients get their products to market as efficiently as possible.
We will design a regulatory and QMS strategy that takes your product to established and emerging markets worldwide.
Device Registrations
> Pre-Market Registration [510(k)| CE Marking| India MDR]
> Specialises in Medical Device Software (SDLC), Design Controls, Risk Assessments & Clinical evaluation as per EU MDR
> Complex Project Management
Leverage our expertise to solve complex regulatory challenges. CONTACT US
CONTACT US
23 New Industrial Road, 04-09 Solstice Business Center, Singapore 536209
shilpi.shukla@medservz.com | +65 9782 7076