…in order to ensure a high level of health protection. What you need to know You can gather from the doctor’s poignant introduction, I am not a big fan of…
…in order to ensure a high level of health protection. What you need to know You can gather from the doctor’s poignant introduction, I am not a big fan of…
…system compliant with Annex II or V of the Directive. How is compliance achieved? The doctor is a big proponent of EN ISO 13485:2003. That said, the only sure-fire way…
…system compliant with Annex II or V of the Directive. How is compliance achieved? The doctor is a big proponent of EN ISO 13485:2003. That said, the only sure-fire way…
…application of the classification rules, the identification of essential requirements, and the appropriate path for conformity within the EU. Dr. D has always been a big proponent of selecting competent…
…application of the classification rules, the identification of essential requirements, and the appropriate path for conformity within the EU. Dr. D has always been a big proponent of selecting competent…
…procedure for complaints. In fact, this device manufacturer saw no real value or purpose in opening complaint files. I think this type of performance deserves a big “Duh, duh-duh,” thanks…
…procedure for complaints. In fact, this device manufacturer saw no real value or purpose in opening complaint files. I think this type of performance deserves a big “Duh, duh-duh,” thanks…
…cited by the agency. As my readers are keenly aware, the doctor is very big on procedures and the application of DG Rule # 6 – All procedures, work instructions,…
…cited by the agency. As my readers are keenly aware, the doctor is very big on procedures and the application of DG Rule # 6 – All procedures, work instructions,…
…D supports a well-documented approach to reduced inspection activities, especially at RI. I am a big proponent of establishing a fundamentally sound and statistically-based approach to inspection, executed by the…
…D supports a well-documented approach to reduced inspection activities, especially at RI. I am a big proponent of establishing a fundamentally sound and statistically-based approach to inspection, executed by the…
…I am big on supplier corrective action and the employment of the Supplier Corrective Action Request, a.k.a., SCAR. Supplier non-conformances are a major component and significant gage for over all…
…I am big on supplier corrective action and the employment of the Supplier Corrective Action Request, a.k.a., SCAR. Supplier non-conformances are a major component and significant gage for over all…
…the Gage R & R Study, in house, to ensure you (a medical device manufacturer) and your supplier, achieve the same results. I am a big proponent of Minitab™ for…
…the Gage R & R Study, in house, to ensure you (a medical device manufacturer) and your supplier, achieve the same results. I am a big proponent of Minitab™ for…
