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Medical Devices

Funding Trends – Medical Device Industry

Acc. to the EY Lifesciences 2015 report, US medical device companies raised approximately $47 billion in 2015

Medical Devices

Safety Concerns of Raw Milk Cheese

If you're lactose intolerant you don't have to worry, But if you aren't you should

Medical Devices

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?

Medical Devices

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!

Medical Devices

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.

Medical Devices

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.

Medical Devices

3D Imaging Software – The Vision of Medicine

Any sufficiently advanced technology is indistinguishable from magic.

Medical Devices

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.

Medical Devices

Is your medical device exempt?

All devices are classified in accordance to the 16 device Classification Panels.

Medical Devices

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.

Medical Devices

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.

Medical Devices

Can Wearable Devices Compete With Hospital Capital Equipments?

Real-time patient care and monitoring has become the crux of the medical industry.

Medical Devices

5 tips for a successful 510(k) submission

Hope these tips come handy for your next submission!

Medical Devices

Refuse to Accept policy

Unsure about what should be covered in a 510(k)?

Medical Devices

Intended use and indications for use

How to differentiate between the two? To know more click here

Medical Devices

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?

Medical Devices

510(k) flowchart

FDA has laid out characteristics essential for the review of 510(k) submission.

Medical Devices

510(k)

510(k) is a pre-market submission filed at the FDA by the manufacturer who intends on releasing a medical device.

Medical Devices

PMA Submission

PMA is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III devices

Medical Devices

Is my product a Medical Device? – Knowing the difference

Determine if your product meets the Definition of a device.