Medical Device Manufacturing
Medical Device Manufacturing
Complying with such regulations appears to be keeping members of the C-suite up at night. A recent Emergo survey found that 66% of senior device executives are most concerned with regulatory changes that could affect their companies. As the survey noted, these concerns are not new and are coming as the international device market experiences rapid growth. The medical device industry faces many challenges in terms of managing products along the supply chain. Because companies work with vendors around the globe, they must project inventories, manage just in time supply deliveries, and predict warehousing needs, all while maintaining specified levels of quality. Our solutions support quality planning, continuous monitoring and quick problem solving. They can support information sharing and control quality processes across the supply chain. Wherever your company is located, combining powerful EPP functionality with the cloud should prove transformative by eliminating costs associated with IT staffing and software maintenance, improved operations and security, and enabling mobile access anytime, anywhere. The savings resulting from adopting such a platform could be invested in other areas (including R&D) to help medtech manufacturing and distribution companies meet the fast-paced challenges of today and tomorrow’s world.
When organizations run different systems — for manufacturing, procurement, finance, compliance and people — it’s inefficient, error-prone and costly. Figures from different systems rarely match, so management lacks a definitive version of the truth with which to make decisions.
Supply Chain Pressure
Companies need to maximize efficiency among networks of often far-flung suppliers, while reducing costs and improving responsiveness. When governments cut project budgets, only the most efficient supply chains can do so while maintaining profitability.
Cyber Security Regulations
Companies are seeing higher demands for compliance and auditability under DFATRS and ITAR and may face criminal or other penalties if they fall short. The stakes are immense. n companies meet the fast-paced challenges of today and tomorrow’s world.
- Establish QMS practices
- Demonstrate Compliance
- Manage Risk
- Configurability to meet departmental requirements
- Real time business intelligence
- Ability to streamline business processes
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Learn how VistaVu and this leading ERP system enable companies to meet FDA 21 CFR Part II 8 EU Annex 11.
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DOWNLOAD this FREE WHITEPAPER
Learn how VistaVu and SAP Business ByDesign for MedTech Manufacturing Enables Companies to Meet Compliance and QA Requirements for FDA 21 CRF part 11 and EU Annex 11
- Ensure delivery of high quality results (products and processes)
- Easily expand into new markets
- Manage customer demand with robust forecasting. planning, processes & inventory management
- Deliver a real time, integrated customer view of your business enabling the right decisions – faster
- Meet necessary regulatory compliance with trackable & traceable, digitally-managed documents
- Avoid additional IT costs and reduce operational Costs
- And more…
Watch the Video:
Introduction to SAP Business ByDesign For Manufacturing