regemon.com

RegéMon LLC - Welcome

Regulatory Affairs and Quality Systems Consulting. Regemon is a consulting. Firm assisting medical device and biotechnology companies in the area of quality, regulatory compliance and clinical services. Enjoy the benefits of external regulatory and compliance support to provide a specific expertise or to manage workload during personnel shortages or high workload situations. Our services are focused on assisting small and mid-size companies achieve regulatory compliance with FDA. Contact Us: Christof Lit...

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RegéMon LLC - Welcome | regemon.com Reviews

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Regulatory Affairs and Quality Systems Consulting. Regemon is a consulting. Firm assisting medical device and biotechnology companies in the area of quality, regulatory compliance and clinical services. Enjoy the benefits of external regulatory and compliance support to provide a specific expertise or to manage workload during personnel shortages or high workload situations. Our services are focused on assisting small and mid-size companies achieve regulatory compliance with FDA. Contact Us: Christof Lit...

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RegéMon LLC - Welcome | regemon.com Reviews

https://regemon.com

Regulatory Affairs and Quality Systems Consulting. Regemon is a consulting. Firm assisting medical device and biotechnology companies in the area of quality, regulatory compliance and clinical services. Enjoy the benefits of external regulatory and compliance support to provide a specific expertise or to manage workload during personnel shortages or high workload situations. Our services are focused on assisting small and mid-size companies achieve regulatory compliance with FDA. Contact Us: Christof Lit...

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RegéMon LLC - EU (CE) Compliance

http://www.regemon.com/page2.html

Regulatory Affairs and Quality Systems Consulting. Training: Regulatory/ Quality/ Compliance. Regemon provides customized in-house training for individuals, small or large groups, organizations’ management or production personnel working in FDA- or ISO-regulated environment. 21 CFR 820 Quality System Regulations. Quality System Regulations for Management. Quality System Inspection Techniques (QSIT). CAPA process and effective Root Cause Analysis. Complaint Handling and 21 CFR 803 Medical Device Reporting.

2

RegéMon LLC - EU (CE) Compliance

http://www.regemon.com/page3.html

Regulatory Affairs and Quality Systems Consulting. Preparation of Technical Files and Design Dossiers. Assistance in the implementation of a Quality System in compliance with ISO 13485, ISO 9001 and EN ISO 14971: 2012. Interaction with Notified Bodies and Competent Authorities in the European Union. Development and implementation of a compliant EU Vigilance System. Training: CE Marking and EU Directives for Medical Devices. Contact Us: Christof Littwitz * 1.210.296-9236 * clittwitz@regemon.com.

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RegéMon LLC - Contact Us

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Regulatory Affairs and Quality Systems Consulting. Call or Email for a free consultation:. Contact Us: Christof Littwitz * 1.210.296-9236 * clittwitz@regemon.com.

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RegéMon LLC - Quality Systems

http://www.regemon.com/page1000.html

Regulatory Affairs and Quality Systems Consulting. Performing Quality System Gap Assessments (FDA QSR, MDD, JPAL, CMDCAS, ISO 13485). Development and implementation of a sustainable Quality System (FDA QSR; MDD, CMDCAS, ISO 13485 and ISO 9001). Conducting Due Diligence audits. Internal and external (supplier) audits. Conducting Mock FDA Inspections. Customized In-house Quality System Training. Assist in choosing the right Notified Body.

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RegéMon LLC - Regulatory Compliance

http://www.regemon.com/page11.html

Regulatory Affairs and Quality Systems Consulting. Regemon consultants provide practical solutions and work with you to develop and implement effective regulatory strategies. Prepare domestic and international regulatory submissions. And foreign regulatory agencies (EU Notified Bodies, SCC, MHLW, SFDA, etc) inspections. Your employees in all aspects of regulatory compliance. CE Design Dossiers, CE Technical Files, Health Canada class II, III and IV Submission Files, STED. FDA Enforcement Action resolution.

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RegéMon LLC - Welcome

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