…A panel with representatives from two dozen agencies, organizations and large device makers such as Medtronic Inc., Aetna Inc. and the American Medical Association, prepared the report that was commissioned…
…A panel with representatives from two dozen agencies, organizations and large device makers such as Medtronic Inc., Aetna Inc. and the American Medical Association, prepared the report that was commissioned…
Happy Chinese New Year….the year of the ram! There are very good opportunities for foreign medical device companies in China because the people are becoming wealthier and want better healthcare….
Happy Chinese New Year….the year of the ram! There are very good opportunities for foreign medical device companies in China because the people are becoming wealthier and want better healthcare….
…complete. In the medical device industry, those are most likely to be the compliance activities—maintaining traceability, linking requirements to source code and testing to requirements, and so forth. After identifying…
…complete. In the medical device industry, those are most likely to be the compliance activities—maintaining traceability, linking requirements to source code and testing to requirements, and so forth. After identifying…
…resources readily available in one place, we make it easier for life sciences organizations to get their products and services to market quickly and safely. Visit www.linkedin.com/company/sgs-life-sciences for more information….
…resources readily available in one place, we make it easier for life sciences organizations to get their products and services to market quickly and safely. Visit www.linkedin.com/company/sgs-life-sciences for more information….
…attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s safety alerts page. (2015, February). FDA.gov Website. Retrieved February 21, 2015, from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htmsource=govdelivery&utm_medium=email&utm_source=govdelivery….
…attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s safety alerts page. (2015, February). FDA.gov Website. Retrieved February 21, 2015, from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htmsource=govdelivery&utm_medium=email&utm_source=govdelivery….
Medtronic Plc, which recently completed the $49.9 billion acquisition of Ireland-based Covidien Plc, posted better-than-expected third-quarter profits, driven by solid growth in its cardiac and vascular business. The company’s heart…
Medtronic Plc, which recently completed the $49.9 billion acquisition of Ireland-based Covidien Plc, posted better-than-expected third-quarter profits, driven by solid growth in its cardiac and vascular business. The company’s heart…
The medical device approval process has become more difficult as FDA guidelines and compliance mandates grow increasingly stringent. As a result, many companies face the challenge of maintaining healthy growth…
The medical device approval process has become more difficult as FDA guidelines and compliance mandates grow increasingly stringent. As a result, many companies face the challenge of maintaining healthy growth…
…820 Compliance. Charleston, SC: Amazon. DuPont™ Tyvek® Medical Packaging Transition Project (MPTP). (2015, February). http://www.dupont.com/products-and-services/packaging-materials-solutions/pharmaceutical-packaging/brands/tyvek-sterile-packaging/uses-and-applications/tyvek-medical-packaging-transition.html FDA’s enforcement page. (2014, December). FDA.gov Website. Retrieved February 16, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm433090.htm ISO 11607-1…
…820 Compliance. Charleston, SC: Amazon. DuPont™ Tyvek® Medical Packaging Transition Project (MPTP). (2015, February). http://www.dupont.com/products-and-services/packaging-materials-solutions/pharmaceutical-packaging/brands/tyvek-sterile-packaging/uses-and-applications/tyvek-medical-packaging-transition.html FDA’s enforcement page. (2014, December). FDA.gov Website. Retrieved February 16, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm433090.htm ISO 11607-1…
…M&A activity over the last year. Globalization: PLS companies searched for partners and acquisition targets outside of the US to create business synergies and open up new markets. Cross-border transactions…
…M&A activity over the last year. Globalization: PLS companies searched for partners and acquisition targets outside of the US to create business synergies and open up new markets. Cross-border transactions…
According to Canadian medical technology trade group MEDEC, the new requirement will apply to all commercially reprocessed single-use devices, but Health Canada will leave in place provincial- and territorial-level oversight…
According to Canadian medical technology trade group MEDEC, the new requirement will apply to all commercially reprocessed single-use devices, but Health Canada will leave in place provincial- and territorial-level oversight…
