An integrated, best-in-class commercial approach
Certara’s MedTech specialists partner with medical device and diagnostic clients to reduce risk and accelerate approvals using advanced technology, an integrated approach, and industry-leading expertise. At any stage of the product lifecycle, our team of experts leverages extensive experience and knowledge of medical writing, regulatory pathways, commercialization, and lifecycle management to provide the unique support you need to advance your program and increase regulatory success.
As an extension of your team, we are uniquely positioned to anticipate and avoid risks, provide concrete insights to drive informed decisions, and deliver success for your MedTech program.
Deliver end-to-end consulting support
Our medical device experts perform gap assessments and clinical/performance evaluations to analyze risks and provide strategic input, ensuring you are prepared to meet evolving regulations.
Navigate global regulatory complexities
Medical device regulations are changing around the world. Our experienced team takes the guess work out of compliance with MEDDEV 2.7/1 Rev 4, EU Medical Device Regulation (MDR) 2017/745, In Vitro Diagnostic Regulation (IVDR) 2017/746, Brexit, and MDCG guidance documentation.
Elevate technical documents for submission success
Whether your documents need to be created or updated, our medical and scientific writing team delivers high-quality assets for your submission.
- Clinical Evaluation Plan (CEP) / Performance Evaluation Plan (PEP)
- Clinical Evaluation Report (CER) / Performance Evaluation Plan (PEP)
- Literature Search Protocol
- Literature Search Report
- Post-Market Surveillance Plan
- Post-Market Surveillance Report
- Post-Market Clinical Follow-Up Plan
- Post-Market Clinical Follow-Up Report