Expediting Market Access & Ensuring the Success of Your Medical Product

PORTFOLIO

Consulting & Support in the following areas

Cycling

Regulatory Affairs

Quality Management

Engineering & Innovation

Clinical Evaluations

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

Nadine Bachmann

Administration

MedtechXperts GmbH

Recent Projects

Abstract

Restructuring and updating the risk management process and documentation, to increase efficiency, to ensure alignment with present-day international quality and regulatory requirements and to enable risk-based product development according to ISO 14971: 2012

Updating Clinical Evaluations based on the new EU MEDDEV Guidance 2.7/1 revision 4 and in accordance to the current regulatory requirements and international standards ISO 14155

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