INDUSTRY PERSPECTIVES

Medtech Cybersecurity: 6 Elements Of An Effective Responsible Disclosure Policy
Medtech Cybersecurity: 6 Elements Of An Effective Responsible Disclosure Policy

A responsible disclosure policy tells cybersecurity researchers that, if they find a vulnerability in your device, they can tell you about it without fear of legal reprisals. FDA strongly recommends adoption of such a policy as a security practice for all manufacturers. Here’s what you need to know to be prepared for the new guidelines.

More Industry Perspectives

WHITE PAPERS & CASE STUDIES

Metallographic Examination Of Medical Implants

Metallographic examination has become an indispensable tool in the testing, quality control, failure studies, and post-mortem analyses of implantable devices. This paper presents techniques and results for examination of titanium-based acetabular cups and Co-Cr-Mo femoral hip stems and knees.

4 Avenues To Leveraging A Smartphone In Your Connected Health Product

Connectivity has evolved alongside the proliferation of the smartphone and the two are coming together to redefine how we manage our health. Considerations such as durability, battery life, security, user experience, and much more must be considered as you develop a connected medical solution, but the principal consideration for any smartphone is its principal purpose: Connectivity and communication.

Laser Marking Metal For Medical Applications

Medical product marking and decoration is used for inventory control, process management and internal tracking, branding, and functionality. In many cases, lasers provide the preferred means of marking and identifying those products.

A Crash Course In Choosing Biocompatible Wearable Tech Materials

What is the best part about wear­able tech­nol­ogy prod­ucts? You can wear them while they work! This also indi­cates, how­ever, that your wear­able device must be made of an appro­pri­ate mate­r­ial to be worn safely. 

More White Papers & Case Studies

PRODUCT & SERVICE SHOWCASE

Contract Manufacturing for Single Use Finished Medical Devices Contract Manufacturing for Single Use Finished Medical Devices

Passion for technology has driven SMC Ltd. to be a leading manufacturing partner to the top medical device OEMs. With operations spanning the United States, Costa Rica, and India, SMC is positioned to assist you on your next finished medical device.

 

Lab Testing and Sterilization Validation Services Lab Testing and Sterilization Validation Services

REVOX has put together a team comprised of engineers, chemists, microbiologists, project managers, business consultants, and quality and regulatory professionals that are subject matter experts with strong expertise and experience in their fields. With such a team, REVOX can work to enable their sterilization technology to work to its fullest potential for medical devices. The company offers rapid 30-day sterilization development, materials and microbiological laboratory testing, supply chain optimization services, and regulatory development expertise.

As with any sterilization method, the REVOX room temperature PAA sterilization process must prove sterility using one of two testing methods—the overkill method or the bioburden method.  

Medical Device Engineering Services Medical Device Engineering Services

Phase 2 Medical employs an engineering team with vast experience in the complexities of assembling, testing, and packaging single-use, disposable medical devices. Their engineers specialize in the LEAN manufacturing of medical devices.

Avalanche Photodiodes (APDs) Avalanche Photodiodes (APDs)

First Sensor has a large selection of high sensitivity, high speed and low dark current photodetectors optimized for ultraviolet, visible and infrared light as well as ionizing radiation. Package solutions include surface mount (SMD), through hole (THD) devices

Lead Frame / Insert Micromolding Lead Frame / Insert Micromolding

Accumold's tooling and automation systems for lead frame molded parts and insert applications are second to none. Components can be singulated and shipped bulk, or tape-and-reel to our customers.

Custom Prisms Custom Prisms

Precision Optics Corporation can custom manufacture prisms with tolerances to .01mm, <10/5 scratch/dig, λ/20 flatness, <5 arc second parallelism, +/- 0.1mm; 0.2mm to 150 mm diameter, and +/- 0.02mm (and as thin as 0.2mm) thickness.

More Products & Services

FEATURED SUPPLIERS

STERIS Isomedix Services STERIS Isomedix Services

STERIS Isomedix Services has been committed to providing contract sterilization services to the medical device, pharmaceutical, consumer, and industrial communities for over 40 years. Blending industry-advanced technology with a team approach to Customer service, STERIS Isomedix Services offers the industry’s most comprehensive advantage, encompassing radiation and ethylene oxide sterilization.

REVOX Sterilization Solutions REVOX Sterilization Solutions

REVOX Sterilization Solutions is part of the Cantel Medical Corp.; a company dedicated to infection prevention and control.  Our in house experts include mechanical engineers, chemists, microbiologists, quality assurance and regulatory affairs professionals. The REVOX team will work to understand your challenges, concerns, and opportunities and provide expert insight to help you decide if REVOX Sterilization is the right sterilization solution for your product or product concept, and/or operational efficiency improvement goals.

LATEST HEADLINES

  • FDA Clears LifeWatch's Continuous Vital Signs Monitoring Service

    LifeWatch AG, a leading developer and provider of medical solutions and remote diagnostic monitoring services in the digital health market, is pleased to announce that it has received FDA clearance for its continuous Vital Signs Monitoring Service.

  • Medtronic Gets FDA Clearance For First MRI-Safe CRT-D Devices
    Medtronic Gets FDA Clearance For First MRI-Safe CRT-D Devices

    Continuing its track record of introducing the first magnetic resonance imaging (MRI)-safe cardiac devices to the market, Medtronic recently gained approval from the U.S. Food and Drug Administration (FDA) for cardiac resynchronization therapy defibrillators (CRT-Ds) for heart failure patients undergoing MRI scans.

  • World’s First 3D-Printed Titanium Cranial Implant Cleared By FDA
    World’s First 3D-Printed Titanium Cranial Implant Cleared By FDA

    The U.S. Food and Drug Administration (FDA) has cleared the first 3D-printed cranial/craniofacial plate implant to be made from titanium. Brazil-based BioArchitects’ implant uses Arcam AB’s electron beam melting (EBM) technology to combine the precision and customization of 3D printing with the light weight and high tensile strength of titanium alloys.

  • Former BD CEO Leads $3.5M Investment in Velano Vascular's Needle-Free Blood Draw Device

    Velano Vascular, a medical technology company transforming and enhancing the care experience for hospitalized patients and their practitioners, announced today that the company has raised an additional $3.5 million in funding. Velano will use the proceeds from this financing, an extension of a $5 million Series A financing completed inJanuary 2015, to support the development and commercialization of the company's inpatient blood-draw technology in adult and pediatric populations.

  • St. Jude Launches Mobile OCT Imaging, Angiography System In Europe And Japan

    St. Jude Medical, Inc. has announced the launch of the company’s OPTIS Mobile System in Japan and Europe. The diagnostic system is designed to couple state-of-the-art optical coherence tomography and angiography co-registration with fractional flow reserve technology into one portable system for hospitals with multiple catheterization labs.

  • Boston Scientific Ramping Up Watchman, S-ICD Programs
    Boston Scientific Ramping Up Watchman, S-ICD Programs

    Boston Scientific is ramping up its Watchman anti-stroke device program in anticipation of a National Coverage Determination from the Centers for Medicare & Medicaid Services (CMS). The device maker also is optimistic that it will reverse a decline in cardiac rhythm management (CRM) sales by the end of 2016, based partially on growing adoption of its Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) system.

  • Acquisitions, R&D Focus Drive S&N In 2016
    Acquisitions, R&D Focus Drive S&N In 2016

    Smith & Nephew’s (S&N) multi-year strategy to reorganize and diversify is starting to show results, said CEO Olivier Bohoun. Recent acquisitions in sports medicine and robotic surgery, as well as expanded focus in emerging markets and R&D have accelerated growth, a trend Bohoun expects to continue through 2016.

  • NIH Backs Artificial Pancreas Trial By Partners Cellnovo, TypeZero

    Cellnovo Group is partnering with technology company TypeZero to utilise Cellnovo’s e-connected insulin patch pump alongside its inControl AP software in an artificial pancreas program. This joint system will be in consideration for use in the International Diabetes Closed Loop Trial, which is funded by the National Institute of Health.

More News

UPCOMING TRAINING COURSES

Good Manufacturing Practices (GMP) – An Introduction February 9, 2016
1pm-2:30pm EST, Online Training
Analyzing and Understanding ISO 13485 Proposed Changes February 10, 2016
1pm-2:30pm EST, Online Training
Medical Devices - Effective Complaint Handling and Management February 16, 2016
1pm-2:30pm EST, Online Training
Answering Your Top 5 GCP Questions From 2015! February 17, 2016
1pm-2:30pm EST, Online Training
More Upcoming Courses