Natural Cycles Contraceptive Device
Determining daily fertility through an app that tracks basal body temperatures and period data
Certifying a one-of-a-kind, innovative mobile app under the EU MDR
Services
Industry
The Challenge
As the first of its kind, Natural Cycles had to confront a stiff regulatory framework to be granted EU and US market authorization for their software application as a non-invasive, non-hormonal contraception method. Early on, the company contacted us requesting support to achieve CE marking, at that time under MDD. This marked the beginning of a collaboration that has lasted several years.
The Solution
Our team worked closely with Natural Cycles to build internal expertise and provide guidance that resulted in an approved clinical evaluation from the Notified Body.
We worked with Natural Cycles on various projects within the Quality/Regulatory/Clinical realm including QMS creation and implementation, reviewing SOP, organizing company training to build internal expertise, and clinical evaluation file support for MDR compliance.
We also created an MDR-compliant clinical evaluation file, which involved a two-day clinical evaluation training. Following the training, we frequently met with Natural Cycles to discuss and define strategic and methodological aspects of the clinical evaluation plan and report.
Project Phase 1
We provided support during the creation and implementation of the QMS, reviewed several Standard Operating Procedures, organized company training which aimed to build internal expertise on the requirements and implementation of relevant standards (e.g., IEC 62304 on software lifecycle processes), provided regular service for QMS audit as per ISO13485, MDR, and QSR, and revised parts of Technical Documentation, including risk analysis.
Project Phase 2
We organized a two-day clinical evaluation training to support the creation of an MDR-compliant clinical evaluation file.
Project Phase 3
We initiated a copiloting process during which frequent meetings took place between us and the client to discuss and define strategic and methodological aspects of the clinical evaluation plan and report such as: definition of a state-of-the-art literature search strategy that is compliant with the requirements of MEDDEV 2.7/1 rev 4, description of the relevant state of the art as outcome of the search and appraisal of the retrieved publications, definition of relevant safety and performance parameters from the state of the art that were used as reference for comparison, definition of the appropriate clinical evaluation strategy as per Article 61 of the MDR, and analysis and appraisal of all preclinical and clinical data.
“When embarking on our journey through evolving regulatory frameworks, [Veranex] was a stable, informative resource. The experienced team explained guidelines and closely coached us to the point of submission, where the outcome was positive.”
Dr. Jack Pearson, Medical Affairs Manager at Natural Cycles
Success
We concluded the copiloting process with a complete document review with our clinical evaluation team. We submitted a finalized clinical evaluation to the Notified Body, which was approved in March 2022, helping Natural Cycles successfully close a clinical documentation review.