The FDA’s Center for Devices and Radiological Health issued a statement on medical device supply chain vulnerabilities, the public health impact they have on patient care, the FDA’s actions to prevent and mitigate potential shortages, and solutions to strengthen the domestic supply chain and address these vulnerabilities.

MedTech Intelligence is a professional community for medical technology innovators, medical device & diagnostics manufacturers, digital health & patient care providers, and industry regulators working to develop and maintain healthcare solutions to improve patient outcomes, increase access to care, and reduce healthcare costs. With more than 18,000 online visitors each month and 17,000+ weekly ...

Mar 13, 2024 · While the MedTech industry continues to face significant challenges related to regulatory requirements, cybersecurity issues, recalls and lawsuits, leaders in the industry are navigating and overcoming these areas to push innovation forward like never before.

Dec 20, 2024 · What’s getting R&D attention? The impact of upcoming regulations, A.I., new cybersecurity risks, developments in battery power and innovation, collaborative efforts, and other impacts on the industry in the year ahead.

The MTI Post-Market Surveillance Resource Center provides current news and information specific to maintaining medical device post market product quality & compliance. PMS is a critical component in achieving global Regulatory Excellence to ensure medical devices remain safe, effective, and reliable for end-users.

Jan 2, 2025 · Up until now, the lack of interoperable health-at-home devices has inhibited health technology integration into the home for use in wellness, prevention, managing chronic conditions, and clinical trials.

An April 2024 survey of medical device regulatory professionals illustrates potential regulatory fatigue. See how resource constraints, ever changing global policy, and an underutilization of technology/digital process are impacting internal burden and fatigue and where implementing new regulatory strategies, upgrading organizational expertise, adding outsourced regulatory services are …

Jan 10, 2025 · Acquisition expected to strengthen Stryker’s neurovascular business with Inari VTE product portfolio including mechanical thrombectomy solutions for peripheral vascular diseases such as deep vein thrombosis and pulmonary embolism.

Aug 16, 2024 · The global medical devices market is expected to grow from $542.21 billion in 2024 to $886.80 billion by 2032.As devices become more critical to patient outcomes, regulators around the world are increasing their controls around their manufacturing, distribution, and monitoring – bringing suppliers of these products more closely into line with requirements around pharmaceutical goods.

In the medical device industry, engineering quality is paramount. This is a high-stakes field, and the FDA has zero tolerance for violations. A robust development process not only enhances quality, compliance and efficiency but also boosts profitability.