Medical devices with PLM are one of the most complex and demanding of any manufactured products. Innovation, Competition, regulations, costs and organizational complexity increase your risks and require you to be prepared for a wide range of complications. Despite these complications, you not only have to build the right product, you must also build the product right.
Medical Device companies are under extraordinary pressure to increase profits, reduce risk and meet the demand for innovation while managing fierce global competition, increased regulation and ever-shrinking product development cycles. The best way to stay in control and make better decisions for your development, manufacturing and quality process is a strong PLM solution. Know why the world’s best medical instrument and equipment companies rely on PLM Software solutions to achieve balanced control.
Meeting Medical Devices Industry challenges:
Today’s medical devices manufacturing companies must manage increasingly complex product development processes with the highest efficiency. Product development of medical devices is a very tedious process with FDA.
For the moment, the pressure mounts to meet such challenges as:
- Regulatory requirements of US FDA Regulations 21 CFR Part 803 and 21 CFR Part 807 including part traceability, quality standards and materials compliance require companies to stay in complete control of their product development and all documents created in R&D, manufacturing and the supply chain.
- Quality Standards, Quality, Safety and Regulatory Compliance, including Lean, FEMA, CAPA, 21 CFR Part 820 Quality System Regulation, 21 CFR Part 11 Compliance, ISO 13485, the European MDD (2007/47/EC) and Support for Class 1 ,2 & 3 Devices
- Systems engineering and Risk Management requires companies to manage the risks of many different processes simultaneously as products become a more complex array of functions. To stay competitive, you must leverage development and manufacturing resources and synchronize them around the world.
- Competitiveness is everywhere. New products are introduced every day and growing your market share is difficult. You must be sure to use your resources efficiently, including powerful design and data management tools to increase productivity and introduce best-in-class products to market.
- Rising price of doing business in this industry are affecting all medical device manufacturers. New taxes, scarce resources and rising cost of healthcare require you to take steps to be profitable.
Sensible control of your product development process – Medical instrument and equipment companies need a product development process that fosters innovation, quality and productivity. At the same time, they need to reduce risk and stay in control of complex requirements. PROLIM’s end-to-end PLM solutions enable you to be sure your product features are aligned with your end customers’ needs, as well as marketing and sales expectations.
End-to-end Medical Device Product Lifecycle Management
PROLIM PLM Software’s full set of product lifecycle management solutions enables medical instrument and equipment companies to achieve balanced control, predictable program schedules and costs with competitive capability and performance and performance by taking advantage of:
- Document controls and lifecycle Part traceability, connecting workflows and deliverables from R&D, manufacturing, quality, services and regulatory; reducing risk and enabling re-use for future products
- Integrated engineering applications with world-class features and functions
- Production and process controls with manufacturing, engineering and quality management applications integrated with existing systems to ensure efficiency and quality in development and production.
Building the Product Right with PROLIM PLM
PROLIM enable medical device companies to improve innovation, productivity, and flexibility with greater control of their product development process. Our PLM expertise team make sure to –
- Enable efficient product development process
- Control document and design knowledge
- Facilitate Smooth collaboration
- Optimize production and service
We at PROLIM, offers solutions for leading companies in the medical devices and pharmaceuticals industries, to achieve balanced control, leading to improved visibility to assess and manage risk, reduced time and cost for regulatory submissions and faster ramp up to target production volumes. These proven and flexible solutions speed innovation in medical device development, reduce costs and help insure adherence to global regulations, including FDA compliance.