…that just gave me fits: chemistry. To this day, I break into a cold sweat when there is Jeopardy question on ion-chained reactions in the presence of free radicals (OK,…
…that just gave me fits: chemistry. To this day, I break into a cold sweat when there is Jeopardy question on ion-chained reactions in the presence of free radicals (OK,…
…how the manufacturer of medical devices does not understand the concept of establishing a DHF. Considering the amount of work required in support of compiling a 510(k) or a PMA…
…how the manufacturer of medical devices does not understand the concept of establishing a DHF. Considering the amount of work required in support of compiling a 510(k) or a PMA…
…they continue to insist their interpretation of ISO 19011 is correct, ask for a new auditor that actually comprehends applicable standards and regulations. The doctor also strongly suggests that you…
…they continue to insist their interpretation of ISO 19011 is correct, ask for a new auditor that actually comprehends applicable standards and regulations. The doctor also strongly suggests that you…
…cigars are legal, good bourbon is always free, and the San Jose Sharks finally win Lord Stanley’s Cup. Unfortunately, this world is far from perfect and the medical device industry…
…cigars are legal, good bourbon is always free, and the San Jose Sharks finally win Lord Stanley’s Cup. Unfortunately, this world is far from perfect and the medical device industry…
…Compliance statement for studies stating that the studies were performed in accordance with Part 812 or Part 813 (for example); Rationale for when clinical data comes from just one investigation…
…Compliance statement for studies stating that the studies were performed in accordance with Part 812 or Part 813 (for example); Rationale for when clinical data comes from just one investigation…
…contractor overseeing a new home construction project, it is the systems engineer who ensures that all the architectural pieces come together through the action of the various functional team members…
…contractor overseeing a new home construction project, it is the systems engineer who ensures that all the architectural pieces come together through the action of the various functional team members…
…endless barrage of questions from the reviewer. The doctor’s experience is that if you receive fewer than ½ dozen questions, then pat yourself on the back, you have done well;…
…endless barrage of questions from the reviewer. The doctor’s experience is that if you receive fewer than ½ dozen questions, then pat yourself on the back, you have done well;…
…always be followed in a typical, important investigation. Describe the Problem Describe the Process Identify the Inputs To illustrate the investigation I will use a simple example. A “widget” is…
…always be followed in a typical, important investigation. Describe the Problem Describe the Process Identify the Inputs To illustrate the investigation I will use a simple example. A “widget” is…
…not lead to an increase in properties. Compare the results in your process to the manufacturers data sheet. The manufacturers data sheet may indicate that the material will ultimately reach…
…not lead to an increase in properties. Compare the results in your process to the manufacturers data sheet. The manufacturers data sheet may indicate that the material will ultimately reach…
In the first article, we discussed three key paths for bringing new medical devices to market: designing for commercialization, designing for human trials, and designing for human trials with a…
In the first article, we discussed three key paths for bringing new medical devices to market: designing for commercialization, designing for human trials, and designing for human trials with a…
