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Samantha Jones, Project Manager
Case Studies
Development and Simplification of a Technical File for Clinical Study
Situation
After 10 years for multiple consultants, a small SME with limited resource was struggling to compile a technically advanced but regulatory compliant technical file.
Assignment
Following a formal technical file audit and gap analysis, the fundamental technologies used within the clinical trial were simplified to reduce technical and patient risk as well as opening an easier regulatory pathway. Inadequate documentation was re-written and missing documentation was produced. ECT Healthcare also supported the company during the approval process.
Results
Successful clinical application and trial started on time and on budget.
Transformation and Implementation of an EN ISO13485:2016 Quality Management System
Situation
A large SME needed support for an up and coming EN ISO13485:2016 Quality Management System Audit.
Assignment
Review current SOPs and edit as required; Update and produce suitable training material and implement both new project management and product development processes; Support during the audit.
Results
A successful audit was completed showing adherence EN ISO13485:2016 Quality Management System. Also, on time and on budget, a more efficient and effective product development and project management process was implemented building a strong foundation for the future.
Input and Leadership in the Procurement of the Prestigious European Horizon 2020 SME Grant.
Situation
An SME with no medical device experience required an interim COO to review the Commercial, Product Development and Regulatory strategy. In addition, the company had only weeks to submit to the European Horizon 2020 SME Grant panel following an initial first round rejection.
Assignment
A full review of the company’s Commercial, Product Development and Regulatory Approach. ECT also took the lead in rewriting key areas of the grant application including the commercial, technical and operational approaches as well as bringing in suitable and creditable partners to support the grant application.
In parallel, ECT lead the recruitment of a new commercial lead required to professionalise the companies commercial and health economics programmes.
Results
Only one of two UK based companies to be awarded the grant totally Euro2million. Implemented a full Quality Management System and Regulatory Approach. Along with the new Commercial Director, saw a transformation in Commercial planning and strategy to market allowing further funding plans to be created.
