Ontogen Medtech

Hands-on support to close documentation gaps, resolve inconsistencies, strengthen traceability, and improve alignment across design, risk, verification, and quality records.

Shaping product definition, identifying key risks, and building practical development plans around high-priority unknowns.

Software development services for medical devices ensuring software output withstands scrutiny from regulatory bodies.

Comprehensive preparation, data compilation, and gap assessments for 510(k) submissions to the FDA.

Comprehensive risk management activities including Risk Assessment, Hazard Analysis, FMEAs, and risk mitigation testing.

Early feasibility prototyping to evaluate core functions, mechanisms, and workflows quickly and practically.

Strategic guidance for guiding the development pathway of a medical device, identifying correct product codes and FDA device classifications.

Translation of early concepts into defined user needs, product requirements, and development priorities.

Assistance for medtech teams to untangle incomplete, inconsistent, or disconnected design history files by identifying missing elements and strengthening documentation.

Design verification strategy including testing and analysis under worst-case conditions with statistically valid sample sizes.

Formative and summative usability evaluations documenting user interaction and feedback to comply with IEC 62366.

Assistance in protocol development, regulatory submissions, and ongoing FDA interactions for Class III devices.

Comprehensive testing protocols simulating actual use conditions to verify the product meets user needs.

Facilitating Q-sub meetings to align with the FDA on device classification, compliance requirements, and testing strategies.

Advising and application preparation to secure FDA Breakthrough Device designation for qualifying treatments or diagnostics.

Spearheading interactions with the FDA to request a new product classification when no existing product code fits.

An integrated electric drill system designed to streamline bedside intracranial access, decrease operating room reliance, and facilitate treatment for emerging indications.

A safe, simple and effective portable pulsatile irrigation system for removal of necrotic tissue, exudate, debris, and reduction of bioburden/biofilm.

A point-of-care in vitro diagnostic system that detects nucleic acids of target pathogens, delivering lab-quality results with minimal training.

The first test for the DASH Rapid PCR System, designed to detect SARS-CoV-2 and Flu A/B pathogens.