Medical Devices – CLINEXEL

Your Trusted Partner For Clinical Research and Pharmacovigilance

Medical
Devices

CLINEXEL experts have rich experience in medical device and pharma industry. CLINEXEL team has experience with following devices- stents, ventilators, intraocular lens, respiratory devices, orthopaedic devices, electromagnetic radiation emitting devices, sutures and gloves.

We provide following services for Medical Device Industry:

Pilot clinical trials for investigational devices
Pivotal clinical trials for investigational devices
Post Marketing Clinical Follow-up (PMCF) studies for marketed devices
Preparation of Clinical Evaluation Plans and Clinical Evaluation Reports
Pharmacovigilance activities for Medical Devices including preparation of PSURs

CLINEXEL team is well versed with

ISO 14155:2020
EU-Medical Device Regulation
Medical Device Rules, India

Based on our experience, WE provide strategic regulatory and clinical support for the regulatory approval and CE marking of medical devices.

LET'S E-MEET

We believe in building long-term client relations with an in-depth understanding of your goals, challenges, and the support required. Let us know if you would like to meet with our technical director to learn more about our solutions to your requirements and potential for collaborations. Travel restrictions due to pandemics have limited our opportunities to meet. Until we can meet in person, let’s connect via Zoom meetings.

LET'S E-MEET

We believe in building long-term client relations with an in-depth understanding of your goals, challenges, and the support required. Let us know if you would like to meet with our technical director to learn more about our solutions to your requirements and potential for collaborations. Travel restrictions due to pandemics have limited our opportunities to meet. Until we can meet in person, let’s connect via Zoom meetings.

CLINEXEL is a professionally managed private limited company, a CRO led by experts with experience in leadership positions in pharma and biotech companies .

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