During the design and manufacture of medical devices, weight reduction and materials saving are some of the common pressures that are faced, but in … Our dedicated medical manufacturing team helps you take advantage of the most efficient processes through creating the optimal design for your product realization while adhering to all manufacturing standards and regulations; ensuring you the greatest trust and value in your instrumentation. Center for Devices and Radiological Health DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS This Guidance relates to FDA 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001 Intelligent Design Control increases engineering efficiency and speed across the device lifecycle while avoiding costly errors, quality issues, and recalls. Client Resources. Toggle navigation. Our full service medical device development team can take your from idea through to clinical trials and regulatory approval. Medical device manufacturers are realigning incentives, value chains and business models, as value-based reimbursement models are expected to surpass fee-for-service by 2020. Medical Design Industry.

Call us: 1-877-235-1004 . With increasing co-dependence across engineering domains, tighter integration is necessary to achieve program timelines and deliver … Header Link Menu. Design and Build With Ease and Efficiency. Lewes, Delaware – The global medical devices (MD) market will see a steady growth over the coming years with the sales revenue and international trade value reaching $543.9 billion and $289.2 billion respectively by 2020 driven by aging population, increasing healthcare expenditure and technology advancement.. Design complexity is increasing in all domains as product become ‘smart’ to enable a range of benefits including contextualized / individual therapies, de-centralized care with increasing home use devices, and autonomous or semi-autonomous medical devices.

Secure Client Portal; Conference Room 1; Conference Room 2; Conference Room 3; Services . SOLIDWORKS® software is used by thousands of medical product designers worldwide to develop a wide range of innovative products including U.S. FDA Class 1, Class 2, and Class 3 devices. Before starting to evaluate drug compatibility and leachables from the medical device, an FDA approved drug(s) intended for use with the medical device must be selected. Intelligent Design Control is our solution for medical device companies to become data-driven, model-based, and document smart. Your connected hardware product design and engineering partner. Examples include diagnostic machines, implantable devices, surgical products, and clinical laboratory automation equipment. For today’s health IT and medical device professionals, the choice is clear: disrupt or be disrupted.

Extractables and leachables study design for medical devices where the route of entry for leachables is in a drug product .