Scientifically defensible, submission-ready documentation for EU MDR and FDA medical device regulatory submissions.
Core ISO 10993 documentation services — BEP, BER, and TRA — aligned with the latest 2025 revision and FDA guidance.
The Biological Evaluation Plan is the foundational document of any ISO 10993 biocompatibility strategy. It defines the biological evaluation scope, identifies relevant biological hazards, and establishes the endpoint assessment strategy — including test waivers with scientific justification.
I prepare BEPs that comply with ISO 10993-1:2018 and the updated 2025 revision, structured for EU MDR notified body and FDA reviewer requirements. Each BEP is scientifically grounded, not template-filled.
The Biological Evaluation Report is the comprehensive scientific document that evaluates all available data — literature, existing biological test data, material equivalence data, and chemical characterization — to reach risk-based biocompatibility conclusions for each biological endpoint.
I write BERs that demonstrate scientific rigor to notified body reviewers and FDA. My background in cytotoxicity research and biomaterial science means I understand the science behind each endpoint and can justify conclusions with depth.
The Toxicological Risk Assessment evaluates chemical extractables and leachables from device materials and calculates whether patient exposure levels present an acceptable toxicological risk. This is a critical component of modern ISO 10993 biological evaluation, particularly for devices with complex polymers or coatings.
I prepare TRAs using the Analytical Evaluation Threshold (AET) and Threshold of Toxicological Concern (TTC) approaches as defined in ISO 10993-17 and ISO 10993-18, fully aligned with EU MDR and FDA expectations.
ISO 10993-1:2025 introduced significant changes to the biological evaluation framework, including the lifecycle approach to biological safety and updated requirements for benefit-risk determination. Companies with existing biological evaluation documentation need to assess whether their BEP and BER meet the updated standard.
I perform a structured gap analysis comparing your existing documentation against ISO 10993-1:2025 requirements, identify specific gaps, and provide a remediation plan — or prepare the updated documentation directly.
Submission-ready regulatory documentation for CE Mark technical files and FDA 510(k) biocompatibility sections.
Annex I GSPR §10 Compliance
The EU MDR (2017/745) General Safety and Performance Requirement §10 requires manufacturers to demonstrate that devices achieve intended performance while not compromising patient safety due to material properties. Notified bodies closely scrutinize this section.
Per FDA ISO 10993 Guidance (2020)
The FDA published revised guidance in 2020 on use of ISO 10993-1 for biocompatibility evaluation in device submissions. FDA reviewers expect a structured biocompatibility summary that clearly addresses each endpoint with justification for tests performed or waived.
MEDDEV 2.7/1 Rev.4 Compliant
The Clinical Evaluation Report is a mandatory EU MDR requirement demonstrating clinical evidence for device safety and performance. I prepare CERs structured per MEDDEV 2.7/1 Rev.4, with systematic literature appraisal and clinical data analysis.
Post-Market Clinical Follow-Up
Post-Market Clinical Follow-Up and Post-Market Surveillance documentation is required under EU MDR for maintaining CE Mark. I prepare PMCF plans and reports that demonstrate active surveillance of clinical safety and performance data.
Research-grade scientific writing grounded in published biomaterials and biosensor expertise.
Scientific manuscript writing and editing for biomedical journals. Experience with Elsevier (Bioelectrochemistry, 2025) and Wiley (Advanced Sensor Research, 2024).
EnquirePRISMA-structured systematic reviews for biological evaluation reports and clinical evaluation documentation. Comprehensive PubMed, Embase, and Cochrane searching.
EnquireWhite papers, technical summaries, and grant proposals for MedTech R&D programs and regulatory strategy communications.
EnquireBook a free 15-minute consultation to discuss your device, regulatory target, and timeline. I respond within 24 hours on business days.