new-approach.com
HomeNew Approach Quality System Consultants assist manufacturers of medical devices with compliance to medical device regulations of the US, EU and Canada.
http://www.new-approach.com/
New Approach Quality System Consultants assist manufacturers of medical devices with compliance to medical device regulations of the US, EU and Canada.
http://www.new-approach.com/
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New Approach Quality System Consultants
PO B●●●●2674
Cup●●●ino , CA, 95015-2674
US
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New Approach Quality System Consultants
Brunmeier, Victoria
PO B●●●●2674
CUP●●●INO , CA, 95015-2674
US
View this contact
New Approach Quality System Consultants
Brunmeier, Victoria
PO B●●●●2674
CUP●●●INO , CA, 95015-2674
US
View this contact
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New Approach Quality System Consultants assist manufacturers of medical devices with compliance to medical device regulations of the US, EU and Canada.
new-approach.com
Qualifications of Victoria Brunmeier
http://www.new-approach.com/qualifications_of_victoria_.html
Qualifications of Victoria Brunmeier. Cupertino, CA 95014-2674. Qualifications of Victoria Brunmeier. In the medical device industry since 1988; product experience includes intraocular lenses, in vitro diagnostics, embedded software, orthobiologic products, catheters. Held positions as Chemist, Microbiologist, QC Lab Manager and QA Manager in FDA-regulated firms. Independent Quality System Consultant since February 2002. Health Canada-Certified as an auditor for CMDCAS-recognized audit teams. Member of R...
Client List
http://www.new-approach.com/client_list.html
Qualifications of Victoria Brunmeier. Cupertino, CA 95014-2674. Current and previous clients include:. Acquired by Cytyc which was acquired by Hologic. Now part of Hologic. Aquired by Biosensors International Group. Merged with texcel; now CIRTEC Medical Systems. Acquired by Stryker Neurovascular. Acquired by Boston Scientific. Aquired by Rockwell Automation. Acquired by BARD Peripheral Vascular. Acquired by Boston Scientific. Aquired by Tyco Healthcare; now Covidien.
Consulting Services
http://www.new-approach.com/consulting_services_offered.html
Qualifications of Victoria Brunmeier. Cupertino, CA 95014-2674. We consult on the following medical device regulations:. FDA's Quality System Regulation (QSR). Medical Device Directive (MDD). Canadian Medical Devices Regulations (CMDR)/CMDCAS. Japanese MHLW Ordinance 169. Related standards and regulations. Specifically, we help clients in the following ways:. Review risk management program/risk analyses. Review technical files/design dossiers. Review FDA submissions [510(k), PMA].
Useful Links
http://www.new-approach.com/useful_links.html
Qualifications of Victoria Brunmeier. Cupertino, CA 95014-2674. FDA Medical Devices Home. Code of Federal Regulations (CFR). Search by CFR section, e.g. 2014 21 CFR 820. EC Guidance (MEDDEVs, Consensus Statments, Contact Points). European Commission guidance relating to medical devices. Notified Body Recommendations related to medical devices. Canadian Medical Devices Regulations, SOR/98-282. The date of the current regulation is the last amended on date. Medical Device and Diagnostic Industry Magazine.
Associates | Victoria Brunmeier
http://www.new-approach.com/associates.html
Qualifications of Victoria Brunmeier. Cupertino, CA 95014-2674. Graphic design, branding, software user interface design, package design, web design, video production, photography. Medical device quality system consultant. Check out his blog for great updates and analyses. Barron Park Supply Co. Odd parts for prototypes and fixtures. Helping Silicon Valley pioneers since 1963. Statistical consulting, training and software. Team building with beer! Machine shop for prototypes and fixtures.
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Qualifications of Victoria Brunmeier. Cupertino, CA 95014-2674. New Approach Quality System Consultants provide services to manufacturers of medical devices and in vitro. Diagnostic products. We specialize in companies who sell their products in the European Union, Canada and United States. Please follow the links above to find out about our services and other useful information. We are located in Cupertino, California, in the heart of Biotech Bay (a.k.a. Silicon Valley).
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Skip to main content. For the Public Sector. For Parents and Carers. Dates and Booking Page. A Social Enterprise delivering Positive Social Change. New Approaches is a groundbreaking Social Enterprise using the emerging field of Positive Psychology to deliver Project Management, Business and Strategic Consultancy, Impact Assessment and Training to Businesses and Public Sector organisations. A quote which reflects our ethos. One cannot build on weakness. To achieve results, one has to use all availabl...
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