We’re a global stakeholder relations and partnership building consultancy.
When one considers a group of knowledgeable and experienced professional engineers, medical device and pharmaceutical regulatory consultants, quality assurance and reliability experts, merged with a talented sales team dedicated to online medical supplies, what you get is E & E Medicals and Consulting. We have well-established partners in the EU, Asia, and USA.
We have 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.
We do Quality, Reliability and Safety assessments on medical devices.
We assist and conduct 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 – Product Design Assistance, Test Plan Development, and MTBF Analysis. Our services have been instrumental in making Medical devices safer and more reliable.
We prepare you to sell your medical devices and supplies.
In the first place, selling your medical devices requires 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.
We position our clients at the forefront of their field by advanced services.
Our customers do not only consider us as consultants but as outsourcing partners for medical device regulatory compliances 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.