Funding Trends – Medical Device Industry
Acc. to the EY Lifesciences 2015 report, US medical device companies raised approximately $47 billion in 2015
Safety Concerns of Raw Milk Cheese
If you're lactose intolerant you don't have to worry, But if you aren't you should
The Harmonized ISO 13485 – A Brief Insight!
Can you imagine using life-saving medical devices that have not been certified for quality, safety and efficacy?
Virtual Vital Signs—the Invasion of Medical Devices to our Living Rooms
Have you heard of OvaGraph, The Wheel RE or Ovia? Medical device tech is growing!
Are you designing to meet your customer needs?
Design is a funny word. People think design means how it looks. But, if you dig deeper, it’s really how it works.
HOW TO IMPORT MEDICAL DEVICES INTO THE UNITED STATES
The U.S. market is an attractive market for the import of medical devices with a market size of $110 billion.
3D Imaging Software – The Vision of Medicine
Any sufficiently advanced technology is indistinguishable from magic.
OTC medical device receives FDA 510(k) clearance
Elexes is an expert in global regulatory submissions. We are unique in its delivery speed, quality of work.
Is your medical device exempt?
All devices are classified in accordance to the 16 device Classification Panels.
Breakthroughs in Cardiovascular Treatments – Where Science becomes the Saviour
More than 190 countries together see 17.3 million deaths due to heart problems every year.
Are you making the right claims on your cosmetic products?
Cosmetic substances are appearance or odour enhancers, and have no role to play in anatomical remodelling.
Can Wearable Devices Compete With Hospital Capital Equipments?
Real-time patient care and monitoring has become the crux of the medical industry.
5 tips for a successful 510(k) submission
Hope these tips come handy for your next submission!
Intended use and indications for use
How to differentiate between the two? To know more click here
eCopy
An average 510(k) is at least 35 pages long which means a lot of paper is used. What if all of it was electronic?
510(k) flowchart
FDA has laid out characteristics essential for the review of 510(k) submission.
510(k)
510(k) is a pre-market submission filed at the FDA by the manufacturer who intends on releasing a medical device.
PMA Submission
PMA is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III devices
Is my product a Medical Device? – Knowing the difference
Determine if your product meets the Definition of a device.
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