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Contract Clinical Evaluation Report (CER) Writer – SaMD, AI & Digital Health
We are seeking an experienced CER Writer to support the development of two Clinical Evaluation Reports (CERs) for new Class IIa and Class IIb Software as a Medical Device (SaMD) products in the digital health and mental well-being space. This contractor will independently drive the clinical evaluation strategy and deliver MDR-compliant documentation suitable for Notified Body review.
Key Responsibilities
Author two complete CERs and supporting Clinical Evaluation Plans (CEPs) for Class IIa and Class IIb devices.
Conduct literature searches, clinical evidence reviews, and state-of-the-art assessments.
Evaluate clinical safety, performance, usability, and benefit-risk data.
Assess evidence supporting AI-enabled software functionality and clinical claims.
Collaborate with Regulatory, Clinical, Product, Quality, and Data Science stakeholders.
Identify clinical evidence gaps and recommend mitigation strategies.
Prepare submission-ready documentation in support of CE marking activities.
Required Experience
5+ years of experience writing CERs for medical devices under EU MDR 2017/745.
Demonstrated experience with Software as a Medical Device (SaMD).
Experience evaluating AI/ML-enabled healthcare software.
Strong background in digital health, virtual care, rehabilitation, behavioral health, or mental health technologies.
Proven track record developing CERs for Class IIa and/or Class IIb devices.
Hands-on experience performing literature reviews and critical appraisal of clinical evidence.
- Experience supporting Notified Body submissions and regulatory responses.
Experience with digital therapeutics, remote patient monitoring, or AI-driven clinical decision support tools.
Familiarity with MEDDEV 2.7/1 Rev. 4, MDCG guidance, ISO 14971, IEC 62304, and IMDRF SaMD frameworks.
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