What is MDSAP? MDSAP (Medical Device Single Audit Program) is a jointly leveraged Regulatory Audit recognized by 6 countries/regulatory authorities. C.G. Laboratories utilizes this certification to assist in obtaining private label licensing for Canadian Class 2 medical devices for distribution inside Canada. Benefits of MDSAP Reduction of Regulatory Audits Leverage Regulatory Resources Facilitate marketing authorization where a QMS is a prerequisite Promote consistency and predictability of Regulatory Programs Minimize medical device manufacturing disruptions due to multiple Regulatory Audits For Additional Information contact Russell Crum 817.279.1945 Ext. 1 firstname.lastname@example.org
Did you know that AAMI has a new Certified Industrial Sterilization Specialist (CISS) certification? AAMI has developed a certification program that allows sterilization professionals to showcase their knowledge, experience, and devotion. An industrial sterilization specialist is a person who understands the principles of sterilization process development, validation, control and management as part of the manufacture of healthcare products. C.G. Laboratories has an AAMI Certified Sterilization Specialist (CISS) on staff. A CISS has expertise in the science of sterilization (including, but not limited to microbiology, physics, and chemistry), knowledge of sterilization processing, quality management systems, risk management and regulatory requirements. Recertification requirements for this certification are a combination of work experience and continuing education to demonstrate sustained competency and knowledge in the industrial sterilization field. Russell Crum has 25 years of industrial sterilization expertise and specializes in both Ethylene Oxide and Moist Heat Sterilization: [...]
Do you need decontamination of your medical devices? What are the reasons for decontamination of medical devices? First let’s explain decontamination. Decontamination is the process by which something is rendered free from microbial pathogens. Though much of the process is similar, decontamination is different from sterilization in that it might have environmental microbes, and thus not completely sterile. Also, the item is not to be used on a patient after decontamination. Decontamination typically uses the same methods as sterilization including; liquid chemicals, ethylene oxide gas, gamma radiation, or steam autoclaving that are used by hospitals. Now why would someone need decontamination? Some reasons are… The manager of the quality department of a medical device company is responsible for the complaints of devices. Maybe there is a trend with a particular malfunction and you need to analyze these malfunctions to determine the root cause. So, analysis [...]
Introduction Most people in the medical device industry are aware of the change that is occurring with DuPont’s Tyvek material. Essentially, DuPont is not changing the product, but only changing the manner in which it is manufactured. DuPont is switching to the latest flash-spinning technology in 2015. It is my belief that the majority of the CG Laboratories customers do not want to read all the detail of the testing and learn all of what DuPont has done. They just want to know the bottom line. Therefore this is designed to draw the “bottom line” for CGL customers. For those of you that just want to skip from here and read the summary- go for it! A direct link to lots of information and data is at www.areyouready.tyvek.com. Facts DuPont has been in contact with the US Food and Drug Administration and has developed a [...]
The US Food and Drug Administration (FDA) on Tuesday finalized two guidances detailing when a new 510(k) is required for changes made to medical devices or their software. In August 2016, FDA released the two draft guidances, five years after the agency’s first attempt to replace its 1997 guidance on 510(k) changes. But the agency withdrew the 2011 draft guidance after Congress ordered it to rethink the policies discussed in that version, which industry complained would lead to a major increase in the number of changes that would require a new 510(k). According to FDA, the final versions of the guidances have been updated for clarity and to ensure they are interpreted consistently by agency staff and device manufacturers. While the guidances are largely in line with the 2016 draft versions, FDA has added some additional information to clarify the guidances’ scope. FDA says the [...]
Give C.G. Laboratories, Inc. a call today. We have been decontaminating and testing medical devices for over 30 years We are ISO 13485 certified The success of our customers is one of our Core Values Statements from our customers: “Great customer service, timely, professional and friendly” “Rapid response, on time” “Y’all do things right the first time” “Everyone is fun to work with” Some of the decontamination services we offer: Ethylene Oxide Cidex OPA Steam Call (817) 279-1945 for a Free Quote. We look forward to visiting with you regarding your Medical Device needs.