Expediting Market Access & Ensuring the Success of Your Medical Product

PORTFOLIO

Consulting, Coaching & Support in the following areas

Cycling

Regulatory Affairs

Quality Management

Engineering & Innovation

Clinical Evaluations and Investigations

Publications & Patents

How?

How we address expediting market access & ensuring the success of your medical product?

Employees / Partners have + 20 years of work experience in Medical Device Industry, Research and Technical Industry.

We use a Top-Down Approach in Quality Management and Regulatory Affairs.

Implementing a lean risk-based approach to product development.

In addition, time is taken at the beginning to consider the cornerstones of the project.

Pre-defining triggers in order that important and critical information is considered and incorporated during the project and the development process.

Putting emphasis on the usability of the product.

Who?

Meet Our Team

Stephanie Grassmann

Managing Director

MedtechXperts GmbH

Partners

....

Partner Network

Sandra Wehrt

Administration

MedtechXperts GmbH

Recent Projects

Defining the clinical investigation strategy and subsequently compiling the clinical investigation report in accordance with GCP ICH E6 and FDA 21 CFR Part 812; as well, supporting the compilation of the technical file to obtain FDA clearance of an exoskeleton within three months.

Restructuring the risk management process and documentation, to increase efficiency, to enable risk-based product development, and to ensure alignment with present-day quality and regulatory requirements, including the standard ISO 14971.

Establishing and mapping the clinical evaluation process as well as clinical investigation process in accordance to the current regional (EU MEDDEV 2.7/1)/ international regulatory requirements in alignment with ISO 14155

Revision of the Product Technical File (process, contents, presentation, structure), to increase compilation efficiency and to ensure alignment with current standards, regulations and "State of the Art"

Coaching small companies & start-ups to use a lean approach, to expediate market access of their products