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BILANXCONSULTING.COM

Medical Device Consulting

Consultants for medical device firms, specializing in product risk management, product liability, quality systems and regulatory affairs. Expertise in ISO 13485-2003, ISO 14971-2000, FDA regulations, Canadian regulations, and European Medical Device Directive. Founding member of FDA's Hospital Bed Safety Workgroup.

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Medical Device Consulting | bilanxconsulting.com Reviews
<META>
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Consultants for medical device firms, specializing in product risk management, product liability, quality systems and regulatory affairs. Expertise in ISO 13485-2003, ISO 14971-2000, FDA regulations, Canadian regulations, and European Medical Device Directive. Founding member of FDA's Hospital Bed Safety Workgroup.
<META>
KEYWORDS
1 medical devices
2 product risk management
3 quality systems
4 FDA medical device regulations
5 Canadian medical device regulations
6 EU Medical Device Directive
7 ISO 14971
8 ISO 13485
9 HBSW
10 hospital bed safety
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Medical Device Consulting | bilanxconsulting.com Reviews

https://bilanxconsulting.com

Consultants for medical device firms, specializing in product risk management, product liability, quality systems and regulatory affairs. Expertise in ISO 13485-2003, ISO 14971-2000, FDA regulations, Canadian regulations, and European Medical Device Directive. Founding member of FDA's Hospital Bed Safety Workgroup.

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bilanxconsulting.com bilanxconsulting.com
1

Medical Device Consulting

http://www.bilanxconsulting.com/training.html

Health Product Quality and Risk Management Consulting. We are experienced Trainers in Medical Device subjects, presenting on-site courses to regulators and industry in the US, Ireland, Scotland, Denmark, Sweden, Germany, Czech Republic, Brazil, UK, Canada, and India. Training in medical device quality systems and risk management can be provided on-site or via internet. We can provide customized training on medical device subjects such as ISO 13485, 21 CFR 820, ISO 14971, Process Validation,.

2

Medical Device Consulting

http://www.bilanxconsulting.com/home.html

Health Product Quality and Risk Management Consulting. Medical Device Quality and Regulatory Systems. Provides a balanced approach to development of quality systems, including product risk management, and regulatory compliance in the complex medical device regulatory environment. FDA has stepped up enforcement actions over doubling Warning Letters, prepare before the investigators arrive. Link to our CV on the About Us. Read the new book for Combination Products,. Find our more at PDA's bookstore.

3

Medical Device Consulting

http://www.bilanxconsulting.com/qualitysystems.html

Health Product Quality and Risk Management Consulting. FDA Warning Letter response timelines are strictly enforced. New investigators have been added to the Office of Regulatory Affairs. International inspections have increased. Do you have an inspection procedure? Are your personnel trained in inspection processes? See GlobalCompliancePanel.com, and Complianceonline.com for our web seminars for medical device manufacturers! Additionally, products certified to IEC 60601-1 Third Edition.

4

Medical Device Consulting

http://www.bilanxconsulting.com/aboutus.html

Health Product Quality and Risk Management Consulting. Edwin L. Bills,. Principal Consultant, ELB Consulting. American Society for Quality. Regulatory Affairs Professional Society. For questions and more information on our qualifications see our detailed CV Link below. E-mail us at ed.bills@bilanxconsulting.com. Or call us at 843-810-2157. We also provide medical device design services through our subsidiary 4MED Consulting. ELB Consulting is a Corporate Member of. Powered by Network Solutions.

5

Risk Management Consulting

http://www.bilanxconsulting.com/productrisk.html

Health Product Quality and Risk Management Consulting. Has participated in the development of ISO 14971 medical device risk management standard and can help you develop your own processes and integrate them. In your existing quality system as required under ISO 13485:2003. See our article in Biomedical Instrumentation and Technology. November-December 2008 on Integrating Risk Management in the CAPA Process. Our article in AAMI's. Biomedical Instrumentation and Technology. Recent release of Europe's.

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