Services

Expert Medical Writing Services for MDR Requirements

To ensure your clinical data and evaluation reports meet regulatory requirements, partner with a specialist in medical writing for medical device manufacturers. Heile Töllner Brandt provides a range of medical writing services for medical device companies of all sizes. With experience in both academic research and industry, Heile Töllner Brandt delivers good-to-go deliverables on time and on budget.

Medical Writing with a Consultative Approach

Our process starts with a consultation to get to know your product, your goals, and your challenges. After an initial review, we make recommendations for your medical device submission strategy and present a plan for execution.

Our holistic approach helps ensure all documentation related to your device contains the data needed to meet regulatory requirements. Consider Heile Töllner Brandt your trusted collaborator in the journey from innovation to data analysis to CE mark.

Medical Writing and Consulting Services

CER and PMCF Strategy and Execution

Strategic Consulting

We provide strategy for initial CE marking as well as for your transition to MDR. We execute that strategy by helping you plan PMCF studies (if needed) and by providing high-quality deliverables that meet your objectives and timeline.

MDR Gap Analysis

We review your CER, PMCF plan, and associated documents for MDR compliance and recommend suitable solutions to help you achieve your goals. Whether that involves creating new deliverables or remediating existing documents, we work closely with your team to ensure compliance, clarity, and quality.

Systematic Literature Reviews

Establish the safety and efficacy of your medical device through systematic literature reviews. We conduct the following types of systematic literature reviews:

To establish clinical background and state of the art
To answer scientific research questions
To support a risk management process
And more

All Heile Töllner Brandt partners have extensive experience setting up hypotheses, conducting database queries, and analyzing results. That means you’re ensured a thorough, accurate review and professionally reported results.

Medical Writer Training and Education

Heile Töllner Brandt partners have trained and mentored medical writers and teams for over a decade. With an informative yet engaging approach, we’ll help your medical writers broaden their skillsets so you can make the most of your existing resources.

Ready to discuss your next CER or PMCF project? Contact us today.