MedSurgPI, LLC is proud to announce a partnership with Harmonize Strategy Group, servicing customers as their “on demand, virtual CXO,” providing services and support in corporate and organizational leadership, strategic development, science and technology, innovation, and finance.
President and CEO of Harmonize Strategy Group, Sandra Merkel DeJames, Ph.D., said of the partnership, “We are thrilled to be partnering with MedSurgPI, LLC. The combination of MedSurgPI’s commercially focused medical affairs expertise and Harmonize Strategy Groups’s strategy, leadership and innovation expertise provides customers with the full scope of services required for technology, clinical and commercial development and execution.”
Harmonize Strategy Group LLC provides strategic development for successful execution for:
Management and Partnering
For further information contact:
Peter C. Johnson, MD email@example.com
Gerald L. Klein, MD firstname.lastname@example.org (919-930-9180)
MedSurgPI is expanding our services through our unique partnerships with experienced, dedicated, entrepreneurial consulting companies. In light of the current significant regulatory changes in the EU, increasing our regulatory and clinical expertise in Europe is essential. For that reason, we are proud to announce our new relationship with Sweden-based Devicia, a full-service medical device exclusive CRO. As members of Technical Committees and nominated as experts in international working groups writing medical device standards (such as ISO 14155), we will be able to provide our clients with an industry perspective and first-hand expert advice.
Through this collaboration, MedSurgPI will provide:
MDR & IVDR transit and compliance
Devicia has extensive knowledge of regulatory changes currently taking place in the EU with the implementation of medical device regulation (MDR) and in-vitro diagnostic device regulation (IVDR). Through the collaboration, MedSurgPI and Devicia can assist with regulatory strategy & gap analysis, technical files and design dossiers, classifications, regulatory submissions etc.
A key component in getting or maintaining a CE mark is the Clinical Evaluation Report. All medical devices on the EU market must perform a Clinical Evaluation according to MEDDEV 2.7/1 Rev 4. Devicia’s experienced medical writing team performs clinical evaluations according to the current guidelines and fulfils the requirements of the role of a clinical evaluator.
EU Device Clinical Investigation
Devicia provides full-service support for all kinds of clinical investigations (single center, multicenter multinational RCT’s, registries etc.) both before and after CE mark. Devicia also supports clients with the new MDR requirements for Post Market Clinical Follow up (PMCF). Devicia is nominated as a Swedish expert in the ISO/Technical Committee 194 Working Group 4 governing clinical investigations of medical devices in humans.
Licenses for ISO 14155 Clinical QMS
ISO 14155:2011 is specifically tailored to the requirements for medical device clinical investigations. Through the collaboration, MedSurgPI can offer access through licenses to SOP’s, templates and forms to be able to conduct a clinical investigation according to ISO 14155:2011.