…comparison to the markets in the United States, EU, and Japan. For example, Vietnam, Indonesia and Thailand all import more than 85% of their medical devices. In other words, not…
…comparison to the markets in the United States, EU, and Japan. For example, Vietnam, Indonesia and Thailand all import more than 85% of their medical devices. In other words, not…
Today the FDA has announced the establishment of a website through which anyone can report an allegation of regulatory misconduct. Examples of allegations include promoting or advertising a device outside…
Today the FDA has announced the establishment of a website through which anyone can report an allegation of regulatory misconduct. Examples of allegations include promoting or advertising a device outside…
Risk in the supply chain is an ongoing issue for many global medical device companies. The pressures of cost and regulatory compliance, among other factors, can be difficult to manage…
Risk in the supply chain is an ongoing issue for many global medical device companies. The pressures of cost and regulatory compliance, among other factors, can be difficult to manage…
…C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (June 2016). Inspections, Compliance, Enforcement, and…
…C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (June 2016). Inspections, Compliance, Enforcement, and…
October is National Cybersecurity Month, and FDA is urging companies to raise their level of awareness….
October is National Cybersecurity Month, and FDA is urging companies to raise their level of awareness….
…we look at 2016 and it comes to completion, we’ll see a pretty impressive growth number.” Shareholder-friendly actions. Many companies have focused on stock buybacks and enhancing dividends, all while…
…we look at 2016 and it comes to completion, we’ll see a pretty impressive growth number.” Shareholder-friendly actions. Many companies have focused on stock buybacks and enhancing dividends, all while…
…“Global regulators expect that clinical evaluation and the evidence generated for a SaMD have the same scientific level of rigor that bis commensurate with the risk and impact of the…
…“Global regulators expect that clinical evaluation and the evidence generated for a SaMD have the same scientific level of rigor that bis commensurate with the risk and impact of the…
…communication technology, medical furniture and specialist furnishings for hospitals and physicians’ offices. The COMPAMED trade fair will be held concurrently with MEDICA. With 18,800 visitors last year, COMPAMED broke its…
…communication technology, medical furniture and specialist furnishings for hospitals and physicians’ offices. The COMPAMED trade fair will be held concurrently with MEDICA. With 18,800 visitors last year, COMPAMED broke its…
…medtech companies are software companies, app developers or consumer-focused companies. There are new entrants with well-developed skills that lack the clinical insight and capabilities medtech companies offer. By collaborating and…
…medtech companies are software companies, app developers or consumer-focused companies. There are new entrants with well-developed skills that lack the clinical insight and capabilities medtech companies offer. By collaborating and…
…reviewed product labeling for the SkinPen II, including your firm’s websites located at http://bellusmedical.com/products/skinpen, http://skinpen.com/ and https://www.youtube.com/watch?v=zWRwhi9Yjrc, brochures, and pamphlets, which revealed that the SkinPen II is an automated, non-surgical…
…reviewed product labeling for the SkinPen II, including your firm’s websites located at http://bellusmedical.com/products/skinpen, http://skinpen.com/ and https://www.youtube.com/watch?v=zWRwhi9Yjrc, brochures, and pamphlets, which revealed that the SkinPen II is an automated, non-surgical…
