Truth be told, medical device startups make preventable mistakes. Learn first how to avoid the common mistakes mitigating disaster, saving time, and preventing costly delays. This article breaks down why medical device startups make these mistakes. Then, we’ll outline how to prevent and mitigate them. In short, this article outlines the top mistakes made by […]
Top Mistakes Made by Startups Read More »
News & Blog
A Success Story Unfolds When the Co-founders of Neopenda, Sona Shah, CEO and Teresa Cauvel, CTO approached MAE Group they needed regulatory approval and quality system. Because their life saving product, NeoGuard, was ready for market, they came to MAE Group for their next steps. To be clear, the NeoGuard addresses a health care crisis.
Neopenda: A Success Story Unfolds Read More »
News & Blog, Success Stories
Discover the purpose of a quality management system in the medical device industry.
Quality Management Demystified Read More »
Services
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
Getting a Medical Device to Market: A Step-by-Step Guide Read More »
Resources, Services
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
Getting your Product to Market on Time Read More »
Resources, Services
MAE Consulting Group of the United States and now the United Kingdom, is a business service provider specializing in offering domestic and international regulatory, clinical and compliance services to healthcare companies. With expertise in commercializing medical and in vitro diagnostic devices, MAE Consulting can market your product globally and across the Atlantic — in either direction. The new MAE office
We’re Growing! MAE Consulting Expands to Europe Read More »
MAE Consulting International
The government of India is planning to develop an in-depth regulatory framework for medical devices. The current system lacks distinctive regulatory system and medical devices are either regulated as drugs or are unregulated. Medical devices that are regulated are under the Drug Controller General of India (DCGI) within the Central Drugs Standard Control Organization (CDSCO);
Changes expected with the Indian Medical Device Regulations Read More »
Educational/Training, International Government Regulations
Congratulations – you just received your Clearance Letter from the FDA after months of hard work by a team of dedicated professionals. That Clearance Letter, the CE Marking, and ISO 13485 Certification are the gateway to international markets. You can now move forward to submit dossiers and market your product globally. As you look to
Marketing Your Medical Device Globally and Export Compliance Read More »
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