TechTrade LLC Achieves ISO 13485 Certification

TechTrade has achieved ISO 13485 certification for its Ready-Heat Disposable Medical Heating Blanket with assistance from Emergo Group.

2011-05-25

NEW YORK, NY, May 25, 2011 (Press-News.org) TechTrade LLC, manufacturer of the Ready-HeatTM Disposable Medical Heated Blanket, has achieved ISO 13485 certification as part of its effort to begin marketing its portable heated blankets for treatment of trauma and hypothermia in Europe.

The ISO 13485 certification process took five months to complete and was achieved with assistance from Emergo Group, an ISO 13485 consulting firm serving the medical device industry. TechTrade had previously obtained ISO 9001 certification for a separate product, and the two companies were able to build on that work to implement an ISO 13485-compliant quality system.

With an ISO 13485-compliant quality system in place, TechTrade is now one major step closer to obtaining the CE Marking necessary for commercialization in Europe. Emergo Group will then serve as the European Authorized Representative of the Ready-Heat blanket once it has been approved for sale.

TechTrade's current clients include the US military, which carried out clinical trials of the Ready-Heat product, as well as emergency response providers and hospital groups.

"With Emergo Group it was a hand-in-hand process," says Andrew Shapiro, Product Development Manager at TechTrade. "Emergo Group handled the soup-to-nuts issues in terms of keeping us informed, and helped us leverage our previous ISO 9001 work since there's some overlap there with 13485. They proved highly responsive before, during and after the process."

"ISO 13485 certification is a crucial element of a medical device manufacturer's CE Marking process," says Emergo Group Vice President of Quality Assurance Consulting Richard Vincins. "With an ISO 13485-compliant quality management system now in place, TechTrade LLC has made significant progress in its effort to enter the European medical device market."

About TechTrade LLC
Founded in 2003, TechTrade specializes in developing and manufacturing devices for use in emergency settings. TechTrade's Ready-HeatTM Disposable Medical Heated Blanket is a portable one-time-use device for immediate treatment of trauma, shock and hypothermia used by the US military, EMS, rescue squads, mountain and water rescue, and hospitals around the globe.

About Emergo Group
Emergo Group is a global medical device consulting firm providing a wide range of services for device registration, QMS compliance, clinical trial management, in-country representation, reimbursement and distributor search consulting.

For additional information, please contact:
TechTrade LLC
Andrew Shapiro, Product Development Manager
info@techtradellc.com
1-866-491-8324

[Attachments] See images for this press release:

ELSE PRESS RELEASES FROM THIS DATE:

Migration an overlooked health policy issue: New series

2011-05-25

If internal and international migrants comprised a nation, it would be the third most populous country in the world, just after China and India. Thus, there can be little doubt that population mobility is among the leading policy issues of the 21st century. However, policies to protect migrants and global health have so far been hampered by inadequate policy attention and poor international coordination. This is the conclusion of a new article in PLoS Medicine arguing that current policy-making on migration and health has been conducted within sector silos, which frequently ...

Brisk walking could improve prostate cancer outcomes

2011-05-25

PHILADELPHIA — Men with prostate cancer can improve their outcomes if they walk briskly for at least three hours a week following their diagnosis, according to a recent study in Cancer Research, a journal of the American Association for Cancer Research. "It appears that men who walk briskly after their diagnosis may delay or even prevent progression of their disease," said lead researcher Erin Richman, Sc.D., a research associate at the University of California, San Francisco. Richman said the evidence adds to the growing body of literature that suggests walking regularly ...

The role of bacteria in weather events

2011-05-25

NEW ORLEANS, LA – May 24, 2011 -- Researchers have discovered a high concentration of bacteria in the center of hailstones, suggesting that airborne microorganisms may be responsible for that and other weather events. They report their findings today at the 111th General Meeting of the American Society for Microbiology in New Orleans. "Bacteria have been found within the embryo, the first part of a hailstone to develop. The embryo is a snapshot of what was involved with the event that initiated growth of the hailstone," says Alexander Michaud of Montana State University ...

Bacteria use caffeine as food source

2011-05-25

NEW ORLEANS, LA – May 24, 2011 -- A new bacterium that uses caffeine for food has been discovered by a doctoral student at the University of Iowa. The bacterium uses newly discovered digestive enzymes to break down the caffeine, which allows it to live and grow. "We have isolated a new caffeine-degrading bacterium, Pseudomonas putida CBB5, which breaks caffeine down into carbon dioxide and ammonia," says Ryan Summers, who presents his research today at the 111th General Meeting of the American Society for Microbiology in New Orleans. Caffeine itself is composed of ...

'Genetic predisposition' argument in Canadian courts may diminish influence of other factors

2011-05-25

Using genetic predisposition as a factor in medical conditions presented in Canadian legal cases may diminish the impact of occupational, environmental and social factors in determining health claims, particularly workplace claims, states an analysis in CMAJ (Canadian Medical Association Journal) (http://www.cmaj.ca/embargo/cmaj110260.pdf). Genetic predisposition was cited in 468 legal cases, particularly in labour law, in every province in Canada and the Yukon Territory. The most common references were to conditions affecting the musculoskeletal system (188 cases), such ...

Mexican flu pandemic study supports social distancing

2011-05-25

Eighteen-day periods of mandatory school closures and other social distancing measures were associated with a 29 to 37 percent reduction in influenza transmission rates in Mexico during the 2009 pandemic. The research was carried out by scientists at the Fogarty International Center at the National Institutes of Health and published in PLoS Medicine. The social distancing measures implemented by the Mexican health authorities in spring 2009 were effective in reducing disease transmission by more than one-third, the study found. Social distancing interventions can be implemented ...

Top Benefits of a WYSIWYG Editor for Creating Your Website

2011-05-25

The whole Internet world has gone through a WYSIWYG revolution of late. And, why not? The Internet world believes in keeping things as simple as possible. Gone are the days when people looking at having websites of their own had to contend with surly chunks of HTML codes. In fact, this was so intimidating for most people that they preferred staying without a website rather than go through the learning process that a website builder once entailed. But, today, with the presence of WYSIWYG editors, everything has become simple as pie. The acronym stands for 'What You See ...

Heart failure risk lower in women who often eat baked/broiled fish

2011-05-25

The risk of developing heart failure was lower for postmenopausal women who frequently ate baked or broiled fish, but higher for those who ate more fried fish, in a study reported in Circulation: Heart Failure, an American Heart Association journal. In a large-scale analysis, women who ate the most baked/broiled fish (five or more servings/week) had a 30 percent lower risk of heart failure compared to women who seldom ate it (less than one serving/month). Previous research has found that fatty acids (omega-3) in fish — EPA, DHA and ALA — may lower risk of cardiovascular ...

Injection therapy for sudden hearing loss disorder may be suitable alternative to oral steroids

2011-05-25

Treating idiopathic sudden sensorineural hearing loss with injections of steroids directly into the ear appears to result in recovery of hearing that is not less than recovery obtained with the standard therapy of oral corticosteroids and may be a preferable treatment for some patients to avoid the potential adverse effects of oral steroids, according to a study in the May 25 issue of JAMA. Idiopathic (unknown cause) sudden sensorineural (involving the sensory nerves) hearing loss, a hearing loss with onset in less than 72 hours, has an estimated incidence between 5 ...

Higher levels of primary care physicians in area associated with favorable outcomes for patients

2011-05-25

Medicare beneficiaries residing in areas with higher levels of primary care physicians per population have modestly lower death rates and fewer preventable hospitalizations, according to a study in the May 25 issue of JAMA. "Strengthening the role of primary care is a key element in most proposals to improve the outcomes and efficiency of health care delivery in the United States. With the aging population and the waning interest in primary care by U.S. medical school graduates, some have projected a large shortage of general internists and family physicians to care ...

LAST 30 PRESS RELEASES:

Father’s mental health can impact children for years

Scientists can tell healthy and cancerous cells apart by how they move

Male athletes need higher BMI to define overweight or obesity

How thoughts influence what the eyes see

Unlocking the genetic basis of adaptive evolution: study reveals complex chromosomal rearrangements in a stick insect

Research Spotlight: Using artificial intelligence to reveal the neural dynamics of human conversation

Could opioid laws help curb domestic violence? New USF research says yes

NPS Applied Math Professor Wei Kang named 2025 SIAM Fellow

Scientists identify agent of transformation in protein blobs that morph from liquid to solid

Throwing a ‘spanner in the works’ of our cells’ machinery could help fight cancer, fatty liver disease… and hair loss

Research identifies key enzyme target to fight deadly brain cancers

New study unveils volcanic history and clues to ancient life on Mars

Monell Center study identifies GLP-1 therapies as a possible treatment for rare genetic disorder Bardet-Biedl syndrome

Scientists probe the mystery of Titan’s missing deltas

Q&A: What makes an ‘accidental dictator’ in the workplace?

Lehigh University water scientist Arup K. SenGupta honored with ASCE Freese Award and Lecture

Study highlights gaps in firearm suicide prevention among women

People with medical debt five times more likely to not receive mental health care treatment

Hydronidone for the treatment of liver fibrosis associated with chronic hepatitis B

Rise in claim denial rates for cancer-related advanced genetic testing

Legalizing youth-friendly cannabis edibles and extracts and adolescent cannabis use

Medical debt and forgone mental health care due to cost among adults

Colder temperatures increase gastroenteritis risk in Rohingya refugee camps

Acyclovir-induced nephrotoxicity: Protective potential of N-acetylcysteine

Inhibition of cyclooxygenase-2 upregulates the nuclear factor erythroid 2-related factor 2 signaling pathway to mitigate hepatocyte ferroptosis in chronic liver injury