Clinical Evaluation Reports

Prometheus Medical Technologies now offers a Clinical Evaluation Report writing service.  If a company plans to sell medical devices in Europe, it must produce and maintain a Clinical Evaluation Report (CER) that complies with MEDDEV 2.7.1 revision 4 and the Medical Device Directive (MDD) or Medical Device Regulation (MDR) 2017/745. Such a CER is compiled by assessing and analysing clinical data regarding a medical device to verify the clinical safety and efficacy of the device.

Prometheus Medical Technologies has a team of expert regulatory professionals together with an extremely large network of clinical experts, through our parent company’s clinical training faculty.  Please follow the Device Services tab for more information.

Prometheus DeltaTech achieves ISO 13485 Certification

Achievement of ISO 13485 certification constitutes an important milestone for the company and the Prometheus Medical Group

Prometheus DeltaTech, an innovator and developer of medical technology solutions for the emergency medicine and medical markets, has been granted the international ISO 13485 certification from the National Standards Agency of Ireland (NSAI).

The ISO 13485 Standard specifies the requirements for a quality management system where an organisation must demonstrate its ability to provide medical devices that consistently meet customer needs and regulatory requirements applicable to medical devices.

The achievement of this important objective is a key step towards delivering new products to the European, North American and other global markets over the course of the coming years.  This certification also serves to demonstrate the company’s ongoing commitment to the highest standards for current and future product partners.  As the innovation and product gateway of the Prometheus Medical Group of companies, the achievement of ISO 13485 demonstrates the implementation of best practises throughout the product lifecycle of Prometheus’ offerings.

“Realising the International Organisation for Standardisation certification for quality management emphasises our commitment to the development of safe and clinically effective products” states Dr Keith Real, Chief Executive Officer at Prometheus DeltaTech.  “I’d like to thank the team involved that diligently, passionately and professionally set out to advance our company to this level.  This certification is a significant milestone for Prometheus DeltaTech and provides an important foundation to globally expand our business into other clinical applications, whether organically created or brought to us by partners.”

To find out more about Prometheus DeltaTech, visit: www.prometheusdeltatech.com

Prometheus PIN

PINPrometheus is delighted to announce the launch of our latest product, the Prometheus PIN®.

The Prometheus PIN® has been developed by leading clinicians who understand the need for a high quality, reliable IO device, delivered at an affordable price. The Prometheus PIN® has been designed to be used rapidly, intuitively and effectively. Key benefits of the PIN® include:

  • Rapid and easy IO insertion
  • Single needle solution – one size for all, including paediatrics
  • 15-Gauge needle – pharmacokinetics of which are well established
  • Stabilisation accessory supplied
  • Single-use product – no driver cleaning required between uses
  • No power or battery required for insertion
  • Lightweight and robust
  • Indicated for access to six IO sites
  • Latex-free and non-pyrogenic

If you would like further information on the Prometheus PIN® please contact the office on +44 (0) 1568 613942 or email info@prometheusdt.com

 

Prometheus DeltaTech launches it’s new product – the Prometheus Q-POD™

Apr. 10, 2015Prometheus DeltaTech Ltd, a leading innovator and developer of medical products for the pre-hospital emergency and military markets as well as the general professional healthcare market, is proud to announce the launch of the Prometheus Q-POD.

The Prometheus Q-POD™ is an isolation system for transporting a suspected infectious patient requiring monitoring during transport.  The Q-POD™ is designed to protect the user, the patient and the immediate environment from cross contamination while transporting the patient.

Prometheus DeltaTech currently has many products in development and we continue to follow the philosophy of only bringing products with improvements over the competition to market.  We look forward to launching more products in the near future and to continue to bring relevant solutions to the healthcare market.

Prometheus DeltaTech launches it’s new product – the Prometheus Steady-Head™

Feb. 19, 2015Prometheus DeltaTech Ltd, a leading innovator and developer of medical products for the pre-hospital emergency and military markets as well as the general professional healthcare market, is proud to announce the launch of its latest product, the Prometheus Steady-Head.

Prometheus DeltaTech has an extensive network of industry leading collaborators and develops its products with valuable input from clinical end users.  Such clinical End-user input is invaluable in the development of our products and enables Prometheus to only bring value-adding, high quality products to market.  Recently we have released the Russell PneumoFix and the Prometheus Traction Splint which also cost-effective, simple and intuitive solutions.

The cleaning of head support or immobilisation systems post soiling with bodily fluids has long been regarded as not being optimum from an infection control perspective.  Prometheus DeltaTech has sought to develop an affordable, disposable system that has the flexibility to be used with the varying orthopaedic stretchers and extrication boards on the market.   We have created the Prometheus Steady-Head™ which has a number of features.  These include;

latex free
Steady-Head for website easy and quick to use
 disposable
 comfortable and strong support
 X-ray translucent
utilises reliably adhesive tape
The Prometheus Steady-Head is distributed exclusively by Prometheus Medical so to purchase please contact Prometheus Medical at +44 (0) 1568 613942 or through their website.

Prometheus DeltaTech launches Russell PneumoFix™

The complete chest needle decompression solution has arrived.

Prometheus DeltaTech Ltd, an innovator and developer of medical products for the pre-hospital emergency and military markets as well as the general professional healthcare market announced today (30 April 2014) the launch of the Russell PneumoFix™.

The Russell PneumoFix™ is a sterile decompression needle designed for the treatment of tension pneumothorax, simple pneumothorax, and pleural effusion by appropriately trained medical professionals.  Designed by clinicians and de-engineered for simplicity and effectiveness of use the Russell PneumoFix™ provides a cost-effective, intuitive solution to allow the management of pneumothorax to be dealt with quickly and effectively for the benefit of the patient.

The DeltaTech team is vastly experienced at evaluating ideas and bringing those ideas judged suitable to market.  We are fortunate to have on call a team of product development experts, including clinicians, end-users and regulatory experts that allow us quickly assess an idea and its suitability for partnership.  If you are an end user of medical products and believe you have an idea for a novel product but don’t know what to do next please contact us at lightbulb@prometheusdeltatach.com.

Prometheus DeltaTech launches the Prometheus Traction Splint

Prometheus DeltaTech Ltd, an innovator and developer of medical products for the pre-hospital emergency and military markets as well as the general professional healthcare market announced today (31 March 2014) the launch of the Prometheus Traction Splint.

A traction splint is most typically used to treat severe midshaft fractures of the femur but also fractures of other limbs. The femur is the longest and strongest bone in the human body; the surrounding muscles (quadriceps) are also incredibly strong. When the femur breaks, the surrounding muscles can spasm and may result in pulling the bone ends past each other, which results in immense pain, bleeding (internal or external), and muscle and nerve damage.  The Prometheus Traction Splint is designed to be used on those patients with a suspected limb fracture and its use can decrease the pain and damage caused by the fracture

As with all Prometheus products, it was created with valuable input from end-users and has built in features that are an advancement on the traction splints currently available on the market.  The Prometheus Traction Splint comes complete with a robust and durable pole end extended length straps to cater for an ever increasingly sized population.

Prometheus DeltaTech currently has many products in development and we continue to follow the philosophy of only bringing products with improvements over the competition to market.  We look forward to launching more products in the near future and to continue to bring relevant solutions to the healthcare market.