Scoping Your MDR & IVDR Writing Projects

Scoping Your MDR and IVDR Writing Projects – The Forgotten Step

In most of our webinars, we’ve focused on the writing process including which steps to take and how to organize your thoughts onto paper. However, we’ve never discussed what happens before the writing process begins. So what do you need before you get started?

In this webinar, we’ll discuss the process of scoping a writing project for either MDR or IVDR. We will share the key questions we ask our clients before we start writing and what key inputs are necessary to kickstart the project and ensure you’re starting on the right foot.

We hope to

• Give insight into planning realistic timelines and assessing your team’s bandwidth to complete your project
• Provide examples of key documents and inputs needed early in the writing process
• Describe where these pieces fit within the Clinical Evaluation Report or Performance Evaluation Report templates

Who is this forum for?

Those regulatory, quality and clinical leaders and teams who are tasked with the development, writing, review, or approval of Clinical Evaluation Reports for MDR submissions or Performance Evaluation Reports for IVDR submissions. Anyone interested in learning more about the requirements for these reports is also welcome to attend.

Click here to watch the recording of this webinar.

6 Project Management Secrets Used by Top Medical Writers

I bet when you became a medical writer, you didn’t imagine most of your time would be spent on managerial tasks that don’t involve writing at all. According to one prominent medical writing consultant, most medical writers spend 60% of their time on writing and 40% on project management. As you have likely discovered, the skills required of today’s medical writers go beyond subject matter and regulatory expertise. Given the size and scope of most medical writing projects, this is no surprise. If you find yourself overwhelmed by the project management oversight needed for large projects and overlapping projects involving multiple writers, you’re not alone.

Click here to read these six key tactics to ensure your next medical writing job runs smoothly and meets the necessary requirements.

At Criterion Edge, our clients enjoy our transparency in the services we provide as our candid scoping includes a time frame for delivering the CER and detailed information on gaps in compliance. All of our writers have experience writing CERs and are up to date on current regulations. Providing a comprehensive analysis and subsequent solutions sets us apart from other vendors. Contact us if you would like to have a conversation about what we can do to help with your writing and regulatory needs.