Global’s Medical Writing Capabilities
Project Management including schedule creation and full-service project management for EU MDR deliverables
Training including our regulatory writing internship program, CER essentials course, and custom training programs
Regulatory & Technical Consulting including CER strategy, PMCF strategy, SOP review, and template review
Medical & Regulatory Writing including CEP/CERs, PMCF & PMS Plans/Reports, PSURs, SSCPs, and Literature Reviews
About the Client
Client M is a large medical device manufacturer with a portfolio of products comprising Class IIb and III devices. Client M reached out to GLOBAL shortly after the EU MDR was enacted. Client M was looking for support remediating their portfolio to the new standards.
About the Project
Client M required comprehensive EUMDR remediation services for their portfolio of high-risk devices. Following a recent acquisition, they also needed support in updating and aligning all documentation—including CEPs, CERs, PMCF Plans, and PMCF Reports—to meet their internal standards.
Client M had a skilled internal writing team but had insufficient resources to manage the workload required to meet the impending EU-MDR deadline. Additionally, the expanded portfolio introduced new challenges, such as establishing an effective documentation cadence and integrating the newly acquired devices into their internal QMS system.
Global Solutions
As part of our full-service commitment to Client M, we provided over-arching Project Management services that integrated our team directly into the scoping, planning, and execution of the deliverables.
- GLOBAL writers integrated into Client M’s team to take part in template development, process improvements, project oversight, and cross-functional meetings.
- Weekly meetings between Team Leads allowed teams to work in lockstep to provide high-quality deliverables on-time, on-budget, and in alignment with internal writing strategies.
- Integration with project-management tools enabled GLOBAL to accurately and consistently anticipate the needs of the client’s internal writing team so that GLOBAL was able to provide support and assistance quickly whenever asked.
- Our unique team approach allowed GLOBAL to take on a higher number of assignments than could be executed by single writers. GLOBAL’s high output and efficiency made our services an excellent value and ensured that all key deadlines were met.
- Trips to visit Client M’s campus cemented the close relationship between our GLOBAL team leads and Client M.
- GLOBAL’s project management tools and close-knit relationship allowed us to gain a deep familiarity with Client M’s portfolio. GLOBAL’s writers updated the same documents multiple years in a row; resulting in increased efficiency, improved strategy decisions, and effective incorporation of NB feedback.
Outcome
GLOBAL has maintained a long and successful relationship with Client M thanks to high-quality deliverables, open lines of communication, team integration, and a commitment to supporting Client M’s success. Our integration with Client M’s team has instilled a sense of shared goals and accomplishment which strengthens our bond with our client group.
Conclusions
GLOBAL’s dedication to building strong client partnerships fosters long-term relationships, enabling us to deliver consistent, high-quality outcomes while developing an in-depth understanding of your portfolio. These trusted collaborations enhance efficiency, effectiveness, and the overall quality of deliverables. Partnering with GLOBAL can streamline project management, optimize processes, and alleviate stress and workload for your valuable internal team.