Compliance Corner

Ensuring your product is compliant means staying current on changing Federal requirements and industry regulations. You have enough to do, let our Compliance Corner be your go-to compliance resource. We’ll read the reports, journals, regulations and provide downloads and links to the critical information you need to know – all in one convenient place. Bookmark this page and come back often.

A change to AAMI/ISO 11737-2 affects the Bacteriostasis/Fungistasis test
AAMI Working Group 2 for Radiation Sterilization publishes new TIR 40:2009
Recent views from the FDA on Gentoxicity testing
- Source: FDA.gov
FDA to test BPA Exposure from medical devices
- Medpagetoday.com
"Be in the Know about EtO: Expedited processing and better controls amp up the efficiency of ethylene oxide sterilization while revised standards affect validation"
- Source MPMN, May 2009
"FDA Recommendations to Industry Regarding Outsourcing: How to ensure compliance in the outsourcing environment"
- Source: BioPharm International.com, April 2009
"Benefits of Effective Communication with a Contract Analytical Laboratory: How to handle out-of-specification results in contract analytical work."
- Source: BioPharm International.com, April 2009
"Following the Road to Regulation: FDA's goal is to address the gaps in regulatory oversight of certain diagnostic assays."
- Source: MDDI, February 2010
FDA Inspections for 21 CFR 111 (Dietary Supplements) will become common
- Souce: Labcompliance News.com
"How to Feel Positive about a Biocompatibiity Failure"
- Source: MedicalDeviceSummit

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