Quality Management Demystified
Discover the purpose of a quality management system in the medical device industry.
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Getting a Medical Device to Market: A Step-by-Step Guide
At first turning a concept into a marketable medical device feels daunting. Your great idea solves a critical concern in the health care field, however, the concept itself comprises the first step among many to getting your innovative product safely to market. The next critical steps turns that medical device into a physical product. So
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Getting your Product to Market on Time
So you want to release your medical device or pharmaceutical product into the US or global market for your company expansion goals. Perhaps you are already behind on the timeline and over your budget. In order to get your product to market on time and within budget you need an expert. The Challenges of Getting
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Resources, ServicesProduct Development & Manufacturing
Congratulations! You’ve developed an idea for an innovative product. A great idea is your first step, getting it to market is the next. That’s where MAE Group comes in. We can take your prototype idea, determine how to make it a usable product, and get it safely to market. All the way from creating a
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Program and Project Management
Project management in the drug, medical device and biotechnology industry is the management of various disciplines to achieve one goal: to bring your product to the market within the budgeted project costs, with the available resources and within the agreed timeframe while guaranteeing product quality and safety. With the right project management you can get
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ServicesQuality System Services
MAE Group quality professionals make sure that your company and devices are in compliance to applicable quality system standards and regulations. A compliant quality management system is the backbone of any company and crucial in ultimately gaining regulatory clearance or approval. Maintaining, through objective evidence, good standing with the FDA and other global agencies is
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