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Does a "Significant Change" apply to Class II Medical Devices

WEBcanreg. Feb 15, 2012. #1. We are a distributor of a medical device company in the UK who has a registered Health Canada Class II device. The company will shortly be changing …

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URL: https://elsmar.com/elsmarqualityforum/threads/does-a-significant-change-apply-to-class-ii-medical-devices.52937/

An Introduction to Human Factors in Medical Devices

WEBAn Introduction to Human Factors in Medical Devices By Dick Sawyer Office of Health and Industry Programs CDRH Work Group: Kaiser J. Aziz, Office of Device Evaluation Cathy …

Category: Medical Go Health

HHE (Health Hazard Evaluations) vs. HRA (Health Risk Assessment)

WEBSuper Moderator. Mar 28, 2010. #7. Health Hazard Evaluation (HHE) is a method of classifying recalls and Health Risk Assessment (HRA) is a method of determining the …

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Does FDA allow e-labeling

WEBIt appears that the definitive regulation can be found in Title 21 / Chapter 9 / SubChapter V / Part A / Section 352 (F) which reads: "(f) Directions for use and …

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OHS (Occupational Health & Safety) Objectives and Targets

WEBI am working for a Company which aims at obtaining its Safety Certification (ISO 18001) by end of 2014. Being the team leader in Safety, I have put together a OHS …

Category: Health Go Health

Components, Accessory, or Device

WEBA "component" is defined by 820.3 (c) as "any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part …

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Medical Device Accessory

WEBHi Laudie3, I am not aware of a straight-forward HC definition of accessory, but this might help. HC guidance on Guidance on the Risk-based Classification has a …

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Health Canada Technical File Requirements

WEBBefore registering the high risk devices with HEalth Canada, you must obtain CMDCAS ISO 13485 Certificate. You need to send the technical file to your Certification …

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Canadian Safety Labels for medical electrical equipment

WEBSo, if you apply for an MDL with Health Canada, and you have an electrical medical device then you would have to show (or at least adhere) to the applicable …

Category: Medical Go Health

Language Requirements for Medical Devices: Asia

WEBFor updates: www.medical.crimsonlanguage.com 1.877.824.8800 (San Francisco) 1.800.798.9673 (Boston) Country Language Labeling Requirement …

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Rx Only Statement on Prescription Device Product Label

WEBMay 11, 2012. #2. Hello, According to 21 CFR 801.109, only surgical instruments (of all devices not intended for over-the-counter sales) are exempt from the requirement to …

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Procedure Packs / Conveniance Kits Registrations

WEBFredde. We have a number of products registered in Canada. The market has newly enquired if it would be possible to provide some type of “starter” kits or similar with …

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OSHA vs. OHSAS 18001 vs. Work Environment

WEBJun 21, 2001. #6. energy: No link between ISO & OSHA - we're talking regards to 6.4 and the Work Environment. No auditor will ask to see results of OSHA requirements as part …

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Annual Reporting requirements to Health Canada

WEBAug 9, 2012. #5. Re: Annual reporting to Health Canada. Sidney Vianna said: It is part of the auditor's responsibilities to CLEARLY identify a requirement s/he believes it is not …

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Medical Device Regulations

WEBDoes anyone in the forum know if Trinidad and Tobago regulates the importation of medical devices? Our device is web-based software, so my company will …

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OFFICE OF THE SECRETARY ADMINISTRATIVE ORDER

WEBRepublic of the Philippines Department of Health OFFICE OF THE SECRETARY San Lazaro Cpd., Rizal Ave., Sta. Cruz, Manila. 7 May 2004. ADMINISTRATIVE ORDER …

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