Malaysia Medical Device... Marion Weinereb & Associates, Inc. email linked in twitter facebook Consulting and Staffing Expertise in Quality Systems and GXP Compliance Home About... close News Malaysia Medical Device Control Division Issues Series of Guidance Documents on IVD Medical Devices The following are the draft Guidance Documents on IVD medical devices... prepared by Medical Device Control Division for public comment before January 31, 2013. The guidances are based on WHO, ICH and GHTF principles. As Malaysia continues to grow...

on the current TBA/Wooden Pallet issue that has resulted in several drug recalls FDA Recognizes ISO Standard 11040-4 for Glass Syringes FDA: Understanding Barriers to Medical Device... and Biotechnological/Biological Drug Substances IMDRF Issues Recognition Criteria for Medical Device Auditing Organizations IPEC Certificate of Analysis Guide for Pharmaceutical... Excipients 2013 Released Malaysia Medical Device Control Division Issues Series of Guidance Documents on IVD Medical Devices Malaysia Medical Device Control Division Issues Series...

addressed. Read the documentation here. Previous Article Next Article Serving the pharmaceutical, biotechnology, and medical device industries since 1995 Latest News Significant... syringes are used with connecting devices, including connecting devices that conform to the FDA-recognized ISO 594-2 standard. Connecting devices include needles, luer connectors... can be properly connected to connecting devices. Therefore, this guidance identifies additional, technical information that should be submitted by sponsors who seek to rely...

Signup close Welcome to Marion Weinreb & Associates, Inc. MWAs mission is to be the leader in GXP compliance consulting and staffing to the pharmaceutical, medical device... development through commercialization for the pharmaceutical, biotechnology, and medical device industries. MWA sets high standards of excellence in all aspects of the business... is a certified woman-owned business. Learn more about Marion Weinreb s Services Serving the pharmaceutical, biotechnology, and medical device industries since 1995 Latest News Significant...

. Special testing requirement 211.170. Reserve samples Read the FDA guidance here. Previous Article Next Article Serving the pharmaceutical, biotechnology, and medical device... components (drug and device, or biological and device) or taking a streamlined approach whereby the company documents compliance with either the drug GMPs or the QS regulations along... with demonstrating of compliance with specified provisions of the other of the two components. For example, a drug/device combination product, where the drug uses a delivery system...