M E D I C A L Project Management

promedpro.com

Who We Are

At Promedpro, Our Comprehensive project management process integrates supply chain conversions, equipment conversion and implantation , integration needs, data cleaning , training with corporate education and device lifecycle management to ensure a successful implementation of the medical device while meeting regulatory standards and fulfilling user needs

IMPLEMENTATION

PLAN

• Timeline Development

• Resource Allocation

• Risk Assessment
  

COMPLIANCE TESTING

• Testing Protocols
  

• Regulatory Approval

• Quality Assurance
  

ADOPTION AND TRAINING

• Training Program Development
  

• User Training

• Support Services
  

Materials Assessment (M):

• **Scope Definition:** Clearly define the scope of the project, including the specific medical device to be implemented and its intended use.

• **Material Selection:** Evaluate and select materials required for the device implementation, ensuring compliance with regulatory standards and safety requirements.

• **Supplier Identification:** Identify and select reliable suppliers for the materials needed, considering factors such as quality, cost, and delivery timelines

Equipment Validation/Inventory (E):

• **Inventory Assessment:** Conduct an inventory assessment to determine the availability of existing equipment and resources that can be utilized for the implementation process.

• **Equipment Validation:** Validate the functionality and suitability of existing equipment for the intended purpose, or identify the need for new equipment acquisition.

• **Procurement:** Procure any additional equipment or resources required for the implementation, ensuring compatibility with the medical device and adherence to regulatory standards.

Design And Development(D):

• **Project Design: Collaborate with Design teams to develop the necessary modifications or adaptions to the medical device project to meet specific requirements or constraints

• **Project Development: Create Timelines of modified project for implementation , testing and validation purposes, incorporating feedback from stakeholders and end-users.

• **Regulatory Compliance: Ensure that the project design and development process complies with relevant regulatory requirements and standards governing medical devices manufufacturing

Compliance Testing and Certification (C):

• **Testing Protocols:** Develop and implement testing protocols to evaluate the performance, safety, and efficacy of the implemented medical device.

• **Regulatory Approval:** Prepare and submit the necessary documentation for regulatory approval and certification of the medical device.

• **Quality Assurance:** Implement quality assurance measures to ensure compliance with regulatory standards and requirements throughout the testing and certification process.

Lifecycle Management (L):

• **Monitoring and Evaluation:** Establish mechanisms for monitoring and evaluating the performance and usage of the medical device post-implementation.

• **Maintenance and Upkeep:** Implement maintenance schedules and procedures to ensure the continued functionality and reliability of the medical device over its lifecycle.

• **Continuous Improvement:** Collect feedback from users and stakeholders to identify areas for improvement and innovation in the medical device design, functionality, and usability.