Although effective project management practices apply to every business, they are crucial in the medical devices and pharmaceutical industries. Safe and infallible devices must be delivered at the point of usage as human life depends on them.
Successful contract project management requires seamless connection to internal and external processes of the customer. Every company is unique due to their location, market, target group, organization and many other factors, and that is why each case requires an individual approach. SteriPack has a PMI (Project Management Institute) Project Management system build on the PMBOK® Guide. Our Project management processes fall into five groups:
- Initiating
- Planning
- Executing
- Monitoring and Controlling
- Closing
Outsourcing the management of your manufacturing processes ensures you can focus on your core activities and trust that with SteriPack your products are in the hands of experts. From design and development to serial production, manual low volume or fully-automated high-running manufacturing – we are able to help throughout the process. Our Project management knowledge draws on ten areas with specific processes and documents for each of the phases and areas:
- Integration
- Scope
- Time
- Cost
- Quality
- Procurement
- Human resources
- Communications
- Risk management
- Stakeholder management
SteriPack guarantees best practices and engineering know-how in project management and we can pick up new projects from any entry point. Our teams of experts cover product design and development, process implementation, validations, quality compliance as well as vendor management to ensure the customers achieves the expected product outcomes.
Project teams at SteriPack offer:
- Design assistance: design review, concept study, 3D modelling, drawing, creating and updating existing models;
- Technical assistance: process flow, equipment URS’s (User Requirement Specification) and technical specifications, new technology and injection molding advice;
- Quality and regulatory assistance: CE marking 510K, control plans, validation protocols, measurement methods, CT scanning;
- Supply chain management: consigned materials, appointed suppliers and sourcing.
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