…comply with the requirement. Additionally, the Device History Record (DHR) is the receptacle for the complete batch history of finished medical device(s) and must be retained as evidence of compliance…
…comply with the requirement. Additionally, the Device History Record (DHR) is the receptacle for the complete batch history of finished medical device(s) and must be retained as evidence of compliance…
…up time), will always travel the high road, and provide readers with an objective and common-sense approach to compliance. Warning letter violation I hope my readers have visited FDA’s database…
…up time), will always travel the high road, and provide readers with an objective and common-sense approach to compliance. Warning letter violation I hope my readers have visited FDA’s database…
…being maintained. Remember, records are evidence and support compliance or potentially, the lack of compliance. Warning letter violation As I stated in the introduction to this week’s edition of DG,…
…being maintained. Remember, records are evidence and support compliance or potentially, the lack of compliance. Warning letter violation As I stated in the introduction to this week’s edition of DG,…
…adequately compiled or sustained. That said, please remember Dr. D’s mantra; “compliance to regulations is mandatory.” Warning letter violation In this week’s FDA warning letter extraction, the offending medical device…
…adequately compiled or sustained. That said, please remember Dr. D’s mantra; “compliance to regulations is mandatory.” Warning letter violation In this week’s FDA warning letter extraction, the offending medical device…
…opinions and insight for compliance to the QSR. Dr. D does not believe in presentiment in regards to bad things happening when organizations fail to comply with the regulations. If…
…opinions and insight for compliance to the QSR. Dr. D does not believe in presentiment in regards to bad things happening when organizations fail to comply with the regulations. If…
…Conclusion: Compliance premised on well-written procedures I do not find compliance to the quality system regulations particularly challenging or complex. Compliance, in Dr. D’s opinion, is premised on well-written procedures,…
…Conclusion: Compliance premised on well-written procedures I do not find compliance to the quality system regulations particularly challenging or complex. Compliance, in Dr. D’s opinion, is premised on well-written procedures,…
…your inbox from our free weekly newsletter. Mission Statement To educate medical technology product development, design, manufacturing, quality, and regulatory industry professionals with news, analysis, technology and applications content that…
…your inbox from our free weekly newsletter. Mission Statement To educate medical technology product development, design, manufacturing, quality, and regulatory industry professionals with news, analysis, technology and applications content that…
…(b)(4) or for the upgrade made to the Research Version device in (b)(4) which included a new Research Waterload Version and a Waterload Version. 2. Failure to establish and maintain…
…(b)(4) or for the upgrade made to the Research Version device in (b)(4) which included a new Research Waterload Version and a Waterload Version. 2. Failure to establish and maintain…
…training needs, and company employees who are responsible for medical device manufacturing and complaint, CAPA, and Medical Device Report (MDR) handling are not adequately trained to ensure those duties are…
…training needs, and company employees who are responsible for medical device manufacturing and complaint, CAPA, and Medical Device Report (MDR) handling are not adequately trained to ensure those duties are…
…monitor and sustain ongoing compliance to the QSR; and to pursue corrective actions when non-compliances to the QSR or their internal quality procedures are observed. Warning Letter One (February 2010):…
…monitor and sustain ongoing compliance to the QSR; and to pursue corrective actions when non-compliances to the QSR or their internal quality procedures are observed. Warning Letter One (February 2010):…
