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Medical Device Manufacturer Articles & Analysis: Older
30 articles found
Enhancing Product PerformanceSpecialty chemicals play a vital role in the performance and longevity of medical devices. These chemicals are used in coatings, adhesives, sterilization processes, and biocompatible materials that ensure safety and functionality. For example, hydrophilic coatings enhance the comfort and efficiency of catheters, while high-purity ...
The healthcare industry relies on this technology to protect medical devices and products from contamination. Sterile packaging also ensures that facilities and medical device manufacturers comply with industry regulations. ...
These medical device shelf life ISO standards provide guidance on how to determine a device’s expected shelf life — often referred to as the expected lifetime — as well as the testing protocols and procedures manufacturers should follow to ensure a device’s safety and effectiveness over a ...
Precision is not just a preference but a stringent requirement in medical equipment manufacturing. At the heart of this precision lies the role of medical-grade welding gas mixers, an important component in ensuring high-accuracy welding applications, particularly in environments where consistency and quality cannot be compromised. This blog post defines medical-grade welding gas mixers and ...
Many surgeons get great ideas about new medical devices as they solve problems in healthcare. JUNE MEDICAL Founder and Owner Angela Spang have been advising surgeons, entrepreneurs and business owners on device strategy for a long time, and have summarised her thoughts on the great question on IF AND WHEN TO PATENT the innovation. Here is a short overview: Decide if You Need a Patent Decide ...
It also provides a framework for manufacturers to design and develop medical devices that meet the essential requirements. Compliance with the MDD is mandatory for all medical device manufacturers who wish to sell their products within the EU.Obtaining MDD AccreditationTo obtain the MDD, ...
The Brisbane-based designer of the world’s smallest orthopaedic screw has invoiced US hospital suppliers $900,000 in the three weeks since the device gained Food & Drug Administration approval, and he hopes it can soon be made in Brisbane too. Field Orthopaedics, founded in 2016 by former Army doctor Chris Jeffery alongside a team of doctors and engineers including hand surgeon Greg ...
What Differentiates Optics Used in Medical Devices from Other Industries? What distinguishes optical medical devices from other photonic products is not necessarily the use of extreme tolerances or unique manufacturing processes. ...
The pelvic floor physical therapy system is a therapeutic method that uses physical therapy concepts to recondition the pelvic floor muscles in a systematic, effective, and safe manner. The treatment’s purpose is to increase the strength and function of the pelvic floor muscles, as well as to relieve discomfort, weakness, and inefficiency. A qualified physical therapist accesses the muscles ...
This is the area where many of the bio-pharma, consumer healthcare, medical device manufacturers, R&D department, CROs and regulatory agencies face challenges. ...
ByDDi LLC
As a software development and medical device manufacturer, KoKo produces respiratory solutions with high-speed testing, cost-effective lifecycles, and unparalleled accuracy. ...
ByKoKo PFT
In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Kathy Lee-Sepsick, founder and CEO of Femasys. She provides an overview of how the company’s technology is helping women who are dealing with infertility. She also speaks about a ...
A successful and quite common practice for companies, inventors and entrepreneurs to bring their device to market is through contracting Original Equipment Manufacturers (OEM) of medical devices. Contract manufacturing of medical devices is the system by which a ...
Technological Advances in Medical Devices Advances in laser, sensor, and display technology are transforming the capabilities of medical devices. Manufacturers and medical device OEMs are producing devices with more efficiency, accuracy, reliability and ...
Guidance for Industry and Food and Drug Administration Staff Introduction This guidance document provides Food and Drug Administration’s (FDA’s or the Agency’s) recommendations on testing to assess the safety and compatibility of medical devices in the Magnetic Resonance (MR) Environment and the recommended format for Magnetic Resonance Imaging ...
It is an undeniable fact that safety and quality are the top-most priority for medical device companies. However, the best-practices to maintain these priorities are defined under ISO 13485. ...
The US Food and Drug Administration (FDA) requires that all medical devices are identified with a unique device identifier (UDI), in both human and machine-readable forms. These UDI regulations were put in place to enable healthcare providers and manufacturers to more quickly identify flawed devices, leading to ...
As necessary as they are, however, they make the journey to market challenging. Challenges facing medical device manufacturers It’s an industry that’s both exciting and highly regulated. ...
ByEtQ, LLC
The industry is seeing rapid growth due to Covid-19 because medical device manufacturers are having to produce more products at a faster rate. The dielectric properties of fluoropolymers as well as the lubricity and biocompatibility properties are needed to produce personal protection equipment. In the medical ...
Food and Drug Administration (FDA) Medical Device Enforcement and Quality Report, the agency has increased annual inspections at manufacturing facilities by 46 percent since 2007. ...
ByEtQ, LLC