When one considers a group of knowledgeable and experienced professional Engineers, medical device and Pharmaceutical regulatory consultants, quality assurance and reliability experts with dreams of entrepreneurship, merged with a talented sales team dedicated to online medical supplies, what you get is E & E Medicals and Consulting. E & E Medicals and consulting helps medical device companies with a host of FDA regulatory and compliance issues.
As a full-service Regulatory, Reliability Consulting and sales corporation for medical device, Intro Vitro diagnostic device (IVD), Pharmaceuticals, and product lifecycle, we help companies develop and improve advanced medical devices. For quality new medical supplies, E & E Medicals and consulting has the right services for you. E & E Medicals and consulting brings you the most exceptional access to a team of consultants who are very experienced with the U.S Food and Drug Administration (FDA) and healthcare industry.
E & E Medicals and consulting has well-established partners in the EU, Asia, and USA. Our customers do not only consider us as consultants but as outsourcing partners for medical device regulatory compliance through the manufacturing process. Our experts are devoted to guiding you through the process of developing and launching your new product while ensuring that your product meets with postmarket product compliance requirements.
In the first place, selling your medical device allows you to obtain registration and approval from regulatory agencies in each country where you plan to sell your device. Product registration requirements may vary significantly from country to country, which may present challenges for businesses implementing multiple-market strategies.
Depending on where you plan to sell your device(s), successful registration can entail significant effort to meet the pre-market technical and clinical submission criteria or to exploit your current listings and approvals to gain faster access to new markets. With E & E Medicals and advisory partners worldwide, we help companies mark their products.
The consultants have device registration and regulatory compliance services in established markets. E & E Medicals and consulting has assisted and conducted reliability and safety assessment on medical devices for many companies in preparation for FDA approval. Using Reliability Prediction, FMECA (ISO 9000 and ISO 14971), we also offer the following:
Product Design Assistance, Test Plan Development, MTBF Analysis. Our services have been instrumental in making Medical devices safer and more reliable. E & E Medicals and Consulting also makes online ordering and home delivery of medical supplies accessible to our customers at the best prices in the market.