…what is the best design solution; using risk assessments to inform and improve product; using usability testing. I don’t think there’s one most important tool; you should be employing all…
…what is the best design solution; using risk assessments to inform and improve product; using usability testing. I don’t think there’s one most important tool; you should be employing all…
…C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (July 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. (July 2016). Inspections, Compliance, Enforcement, and…
…control of products) Servicing records Process verification and validation (QMS states that if process cannot or is not verified, then validation is required) Sterile packaging validation (Requires procedures for validation…
…control of products) Servicing records Process verification and validation (QMS states that if process cannot or is not verified, then validation is required) Sterile packaging validation (Requires procedures for validation…
Today Zimmer Biomet announced the acquisition of CD Diagnostics, a move that will further strengthen the company’s competitive position in the musculoskeletal market. The two companies formed a co-development and…
Today Zimmer Biomet announced the acquisition of CD Diagnostics, a move that will further strengthen the company’s competitive position in the musculoskeletal market. The two companies formed a co-development and…
In the TV series Star Trek: Voyager, the ship’s Doctor was a computer program called the Emergency Medical Hologram (EMH). The EMH program was built into the starship’s sickbays as…
In the TV series Star Trek: Voyager, the ship’s Doctor was a computer program called the Emergency Medical Hologram (EMH). The EMH program was built into the starship’s sickbays as…
…the Office of Combination Products (OCP) Thinh Nguyen, and Rachel E. Sherman, FDA associate deputy commissioner for medical products and tobacco, explain the concept of the Pre-RFD process and its…
…the Office of Combination Products (OCP) Thinh Nguyen, and Rachel E. Sherman, FDA associate deputy commissioner for medical products and tobacco, explain the concept of the Pre-RFD process and its…
…Compliance. Charleston, SC: Amazon. FDA. (August 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Colombian national charged for unlawfully injecting silicone into victims’ bodies. Accessed August 01, 2016. Retrieved from http://www.fda.gov/ICECI/CriminalInvestigations/ucm514579.htm…
…Compliance. Charleston, SC: Amazon. FDA. (August 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Colombian national charged for unlawfully injecting silicone into victims’ bodies. Accessed August 01, 2016. Retrieved from http://www.fda.gov/ICECI/CriminalInvestigations/ucm514579.htm…
…within or is a permanent component of a device, is an accessory to another device, or is intended to be used for medical purposes that isn’t part of the hardware…
…within or is a permanent component of a device, is an accessory to another device, or is intended to be used for medical purposes that isn’t part of the hardware…
…companies and more accountability placed on a company’s board of directors when data breaches occur. As a result, companies should be implementing processes now to try to get in front…
…companies and more accountability placed on a company’s board of directors when data breaches occur. As a result, companies should be implementing processes now to try to get in front…
…is more complicated now than ever before. Opportunities for Success. Despite the factors discussed, it is possible for device companies to succeed in China. The best way to go, despite…
…is more complicated now than ever before. Opportunities for Success. Despite the factors discussed, it is possible for device companies to succeed in China. The best way to go, despite…
