private:regulatoryconsulting-2
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1440536
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May 31st, 2019 12:00AM
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Regulatory Consulting
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92
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0.00
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Open
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Management Consulting
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May 31st, 2019 10:29AM
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May 31st, 2019 10:29AM
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Since 2006, Regulatory Consulting has provided regulatory affairs and quality systems consulting services to the medical devices and in vitro diagnostics industries. Regulatory Consulting can assist you with a wide range of domestic and international regulatory affairs and quality systems requirements, including:
Regulatory Submissions
•FDA Establishment Registration and Listing
•US Agent for Foreign Manufacturers
•Premarket Notification 510(k)
•Investigational Device Exemptions (IDE)
•Premarket Approval Submissions (PMA)
•Technical File/Design Dossier for CE Marking (MDD and IVDD)
•Health Canada Licenses
•Foreign country regulatory submission
FDA and ISO Quality Systems Requirements
•Quality system audit
•Quality procedure review and gap assessments
•Labeling review and gap assessments
•Design control protocols and report
We will assist you in understanding domestic and international regulatory requirements and delivering your products to market in a timely fashion.
Visit the Services link to find out more about our capabilities and experience.
We also have direct experience networking with a number of experts in product-specific requirements, including product safety engineering to IEC standards, sterilization, biocompatibility, packaging validation, and FDA and IEC laser regulations.
Visit the Links page to access the services of our recommended colleagues.
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Regulatory due diligence., Regulatory submission strategy., Quality management systems., CE marking.
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Open
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2415 Plaza Del Mar
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Escondido
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CA
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US
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92025
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Regulatory Consulting
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private:regulatoryconsulting-2
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1440536
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Mar 23rd, 2018 12:00AM
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Regulatory Consulting
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74
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0.00
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Open
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Management Consulting
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Mar 23rd, 2017 10:51AM
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Mar 23rd, 2017 10:51AM
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Since 2006, Regulatory Consulting has provided regulatory affairs and quality systems consulting services to the medical devices and in vitro diagnostics industries. Regulatory Consulting can assist you with a wide range of domestic and international regulatory affairs and quality systems requirements, including:
Regulatory Submissions
•FDA Establishment Registration and Listing
•US Agent for Foreign Manufacturers
•Premarket Notification 510(k)
•Investigational Device Exemptions (IDE)
•Premarket Approval Submissions (PMA)
•Technical File/Design Dossier for CE Marking (MDD and IVDD)
•Health Canada Licenses
•Foreign country regulatory submission
FDA and ISO Quality Systems Requirements
•Quality system audit
•Quality procedure review and gap assessments
•Labeling review and gap assessments
•Design control protocols and report
We will assist you in understanding domestic and international regulatory requirements and delivering your products to market in a timely fashion.
Visit the Services link to find out more about our capabilities and experience.
We also have direct experience networking with a number of experts in product-specific requirements, including product safety engineering to IEC standards, sterilization, biocompatibility, packaging validation, and FDA and IEC laser regulations.
Visit the Links page to access the services of our recommended colleagues.
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Regulatory Consulting
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private:regulatoryconsulting-2
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1440536
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Feb 17th, 2018 12:00AM
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Regulatory Consulting
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74
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0.00
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Open
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Management Consulting
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Feb 17th, 2018 02:25PM
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Feb 17th, 2018 02:25PM
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Since 2006, Regulatory Consulting has provided regulatory affairs and quality systems consulting services to the medical devices and in vitro diagnostics industries. Regulatory Consulting can assist you with a wide range of domestic and international regulatory affairs and quality systems requirements, including:
Regulatory Submissions
•FDA Establishment Registration and Listing
•US Agent for Foreign Manufacturers
•Premarket Notification 510(k)
•Investigational Device Exemptions (IDE)
•Premarket Approval Submissions (PMA)
•Technical File/Design Dossier for CE Marking (MDD and IVDD)
•Health Canada Licenses
•Foreign country regulatory submission
FDA and ISO Quality Systems Requirements
•Quality system audit
•Quality procedure review and gap assessments
•Labeling review and gap assessments
•Design control protocols and report
We will assist you in understanding domestic and international regulatory requirements and delivering your products to market in a timely fashion.
Visit the Services link to find out more about our capabilities and experience.
We also have direct experience networking with a number of experts in product-specific requirements, including product safety engineering to IEC standards, sterilization, biocompatibility, packaging validation, and FDA and IEC laser regulations.
Visit the Links page to access the services of our recommended colleagues.
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Regulatory Consulting
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private:regulatoryconsulting-2
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1440536
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Feb 16th, 2018 12:00AM
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Regulatory Consulting
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74
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0.00
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Open
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Management Consulting
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Feb 16th, 2017 08:15AM
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Feb 16th, 2017 08:15AM
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Since 2006, Regulatory Consulting has provided regulatory affairs and quality systems consulting services to the medical devices and in vitro diagnostics industries. Regulatory Consulting can assist you with a wide range of domestic and international regulatory affairs and quality systems requirements, including:
Regulatory Submissions
•FDA Establishment Registration and Listing
•US Agent for Foreign Manufacturers
•Premarket Notification 510(k)
•Investigational Device Exemptions (IDE)
•Premarket Approval Submissions (PMA)
•Technical File/Design Dossier for CE Marking (MDD and IVDD)
•Health Canada Licenses
•Foreign country regulatory submission
FDA and ISO Quality Systems Requirements
•Quality system audit
•Quality procedure review and gap assessments
•Labeling review and gap assessments
•Design control protocols and report
We will assist you in understanding domestic and international regulatory requirements and delivering your products to market in a timely fashion.
Visit the Services link to find out more about our capabilities and experience.
We also have direct experience networking with a number of experts in product-specific requirements, including product safety engineering to IEC standards, sterilization, biocompatibility, packaging validation, and FDA and IEC laser regulations.
Visit the Links page to access the services of our recommended colleagues.
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Regulatory Consulting
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private:regulatoryconsulting-2
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1440536
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Feb 15th, 2018 12:00AM
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Regulatory Consulting
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74
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0.00
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Open
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Management Consulting
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Feb 15th, 2017 10:07AM
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Feb 15th, 2017 10:07AM
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Since 2006, Regulatory Consulting has provided regulatory affairs and quality systems consulting services to the medical devices and in vitro diagnostics industries. Regulatory Consulting can assist you with a wide range of domestic and international regulatory affairs and quality systems requirements, including:
Regulatory Submissions
•FDA Establishment Registration and Listing
•US Agent for Foreign Manufacturers
•Premarket Notification 510(k)
•Investigational Device Exemptions (IDE)
•Premarket Approval Submissions (PMA)
•Technical File/Design Dossier for CE Marking (MDD and IVDD)
•Health Canada Licenses
•Foreign country regulatory submission
FDA and ISO Quality Systems Requirements
•Quality system audit
•Quality procedure review and gap assessments
•Labeling review and gap assessments
•Design control protocols and report
We will assist you in understanding domestic and international regulatory requirements and delivering your products to market in a timely fashion.
Visit the Services link to find out more about our capabilities and experience.
We also have direct experience networking with a number of experts in product-specific requirements, including product safety engineering to IEC standards, sterilization, biocompatibility, packaging validation, and FDA and IEC laser regulations.
Visit the Links page to access the services of our recommended colleagues.
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Regulatory Consulting
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private:regulatoryconsulting-2
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1440536
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Feb 14th, 2018 12:00AM
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Regulatory Consulting
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74
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0.00
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Open
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Management Consulting
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Feb 14th, 2017 01:50PM
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Feb 14th, 2017 01:50PM
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Since 2006, Regulatory Consulting has provided regulatory affairs and quality systems consulting services to the medical devices and in vitro diagnostics industries. Regulatory Consulting can assist you with a wide range of domestic and international regulatory affairs and quality systems requirements, including:
Regulatory Submissions
•FDA Establishment Registration and Listing
•US Agent for Foreign Manufacturers
•Premarket Notification 510(k)
•Investigational Device Exemptions (IDE)
•Premarket Approval Submissions (PMA)
•Technical File/Design Dossier for CE Marking (MDD and IVDD)
•Health Canada Licenses
•Foreign country regulatory submission
FDA and ISO Quality Systems Requirements
•Quality system audit
•Quality procedure review and gap assessments
•Labeling review and gap assessments
•Design control protocols and report
We will assist you in understanding domestic and international regulatory requirements and delivering your products to market in a timely fashion.
Visit the Services link to find out more about our capabilities and experience.
We also have direct experience networking with a number of experts in product-specific requirements, including product safety engineering to IEC standards, sterilization, biocompatibility, packaging validation, and FDA and IEC laser regulations.
Visit the Links page to access the services of our recommended colleagues.
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Regulatory Consulting
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private:regulatoryconsulting-2
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1440536
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Feb 13th, 2018 12:00AM
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Regulatory Consulting
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74
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0.00
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Open
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Management Consulting
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Feb 13th, 2017 04:11PM
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Feb 13th, 2017 04:11PM
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Since 2006, Regulatory Consulting has provided regulatory affairs and quality systems consulting services to the medical devices and in vitro diagnostics industries. Regulatory Consulting can assist you with a wide range of domestic and international regulatory affairs and quality systems requirements, including:
Regulatory Submissions
•FDA Establishment Registration and Listing
•US Agent for Foreign Manufacturers
•Premarket Notification 510(k)
•Investigational Device Exemptions (IDE)
•Premarket Approval Submissions (PMA)
•Technical File/Design Dossier for CE Marking (MDD and IVDD)
•Health Canada Licenses
•Foreign country regulatory submission
FDA and ISO Quality Systems Requirements
•Quality system audit
•Quality procedure review and gap assessments
•Labeling review and gap assessments
•Design control protocols and report
We will assist you in understanding domestic and international regulatory requirements and delivering your products to market in a timely fashion.
Visit the Services link to find out more about our capabilities and experience.
We also have direct experience networking with a number of experts in product-specific requirements, including product safety engineering to IEC standards, sterilization, biocompatibility, packaging validation, and FDA and IEC laser regulations.
Visit the Links page to access the services of our recommended colleagues.
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Regulatory Consulting
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private:regulatoryconsulting-2
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1440536
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Feb 12th, 2018 12:00AM
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Regulatory Consulting
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74
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0.00
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Open
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Management Consulting
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Feb 12th, 2017 04:15AM
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Feb 12th, 2017 04:15AM
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Since 2006, Regulatory Consulting has provided regulatory affairs and quality systems consulting services to the medical devices and in vitro diagnostics industries. Regulatory Consulting can assist you with a wide range of domestic and international regulatory affairs and quality systems requirements, including:
Regulatory Submissions
•FDA Establishment Registration and Listing
•US Agent for Foreign Manufacturers
•Premarket Notification 510(k)
•Investigational Device Exemptions (IDE)
•Premarket Approval Submissions (PMA)
•Technical File/Design Dossier for CE Marking (MDD and IVDD)
•Health Canada Licenses
•Foreign country regulatory submission
FDA and ISO Quality Systems Requirements
•Quality system audit
•Quality procedure review and gap assessments
•Labeling review and gap assessments
•Design control protocols and report
We will assist you in understanding domestic and international regulatory requirements and delivering your products to market in a timely fashion.
Visit the Services link to find out more about our capabilities and experience.
We also have direct experience networking with a number of experts in product-specific requirements, including product safety engineering to IEC standards, sterilization, biocompatibility, packaging validation, and FDA and IEC laser regulations.
Visit the Links page to access the services of our recommended colleagues.
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Regulatory Consulting
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private:regulatoryconsulting-2
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1440536
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Feb 11th, 2018 12:00AM
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Regulatory Consulting
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74
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0.00
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Open
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Management Consulting
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Feb 11th, 2017 05:35AM
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Feb 11th, 2017 05:35AM
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Since 2006, Regulatory Consulting has provided regulatory affairs and quality systems consulting services to the medical devices and in vitro diagnostics industries. Regulatory Consulting can assist you with a wide range of domestic and international regulatory affairs and quality systems requirements, including:
Regulatory Submissions
•FDA Establishment Registration and Listing
•US Agent for Foreign Manufacturers
•Premarket Notification 510(k)
•Investigational Device Exemptions (IDE)
•Premarket Approval Submissions (PMA)
•Technical File/Design Dossier for CE Marking (MDD and IVDD)
•Health Canada Licenses
•Foreign country regulatory submission
FDA and ISO Quality Systems Requirements
•Quality system audit
•Quality procedure review and gap assessments
•Labeling review and gap assessments
•Design control protocols and report
We will assist you in understanding domestic and international regulatory requirements and delivering your products to market in a timely fashion.
Visit the Services link to find out more about our capabilities and experience.
We also have direct experience networking with a number of experts in product-specific requirements, including product safety engineering to IEC standards, sterilization, biocompatibility, packaging validation, and FDA and IEC laser regulations.
Visit the Links page to access the services of our recommended colleagues.
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Regulatory Consulting
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private:regulatoryconsulting-2
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1440536
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Feb 10th, 2018 12:00AM
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Regulatory Consulting
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74
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0.00
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Open
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Management Consulting
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Feb 10th, 2017 06:43AM
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Feb 10th, 2017 06:43AM
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Since 2006, Regulatory Consulting has provided regulatory affairs and quality systems consulting services to the medical devices and in vitro diagnostics industries. Regulatory Consulting can assist you with a wide range of domestic and international regulatory affairs and quality systems requirements, including:
Regulatory Submissions
•FDA Establishment Registration and Listing
•US Agent for Foreign Manufacturers
•Premarket Notification 510(k)
•Investigational Device Exemptions (IDE)
•Premarket Approval Submissions (PMA)
•Technical File/Design Dossier for CE Marking (MDD and IVDD)
•Health Canada Licenses
•Foreign country regulatory submission
FDA and ISO Quality Systems Requirements
•Quality system audit
•Quality procedure review and gap assessments
•Labeling review and gap assessments
•Design control protocols and report
We will assist you in understanding domestic and international regulatory requirements and delivering your products to market in a timely fashion.
Visit the Services link to find out more about our capabilities and experience.
We also have direct experience networking with a number of experts in product-specific requirements, including product safety engineering to IEC standards, sterilization, biocompatibility, packaging validation, and FDA and IEC laser regulations.
Visit the Links page to access the services of our recommended colleagues.
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Regulatory Consulting
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