Element’s Life sciences and Biomedical testing services help you optimize your development timelines to get medicines and medical devices to market quickly and safely.
There is no other area of business that is more heavily regulated than the development, testing and distribution of life-saving medicines and medical devices.
As an upcoming leader in testing, verification, and certification, we offer Small and Midsize pharma, CRO’s decades of experience in the field of life sciences/biomedical industry. As a result, we are often a preferred partner for many mid-size pharmaceutical and biotechnology companies and perfectly placed to help you.
- Provide you with the expertise and resources to navigate the complexities of the pharmaceutical and medical device markets.
- Get your products or your customer products to market quickly, safely, and more accurately
- Adhere to best practices, always compliant and conform to regulations.
- Vital support throughout every stage of the drug development cycle – from molecule to market.
Our Service Offerings:
- Quality Assurance
- Quality Engineering
- Digital Assurance
- Next Generation Testing
- IV&V for SAS installations
Our Digital Assurance services is based on the capability we bring to bear from a Medical device testing capability standpoint and also our foundational QA testing process methodology, which further augments our overall service delivery capability.
Our configurable standard QA process is the foundation for providing all specialized testing services to the Lifesciences and Biomedical Industry sector.
Element’s dedicated Medical Devices Testing experts have worked in a consortium based services delivery environment to Verify & Validate Software for surgical instruments, ophthalmology & ultrasound scanners, orthopedic implants & hemodialysis machines, cardiovascular devices such as ECG machines, Holters, Cardiac pacemakers.
Our experts are fully capable of helping Clients test their smart, AI-based medical & healthcare devices such as Intelligent Beds, Infusion pumps etc.
Element follows a 6-step testing approach which is aligned with the development lifecycle enabling a better understanding of the test requirements. Our Risk-based approach to validate the hardware, software and peripheral devices testing allows us to test user & business requirements associated with the intended use of the system.