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MedQ | Full Service CRO for Medical Device Startup Companies | MEDQ

MedQ Consultants B.V. is an EU based full service CRO which provides you a single point of contact to have access to your regulatory, quality and clinical strategy support to bring your medical device to the market and to support post market requirements.

http://www.medq.eu/

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MedQ | Full Service CRO for Medical Device Startup Companies | MEDQ | medq.eu Reviews
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MedQ Consultants B.V. is an EU based full service CRO which provides you a single point of contact to have access to your regulatory, quality and clinical strategy support to bring your medical device to the market and to support post market requirements.
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MedQ | Full Service CRO for Medical Device Startup Companies | MEDQ | medq.eu Reviews

https://medq.eu

MedQ Consultants B.V. is an EU based full service CRO which provides you a single point of contact to have access to your regulatory, quality and clinical strategy support to bring your medical device to the market and to support post market requirements.

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1

Consulting Services | Uncategorised

http://www.medq.eu/pre-and-post-market-clinical-consulting-services

Clinical Trial Support (pre- and postmarket). Quality Consulting and Support. Full range of Support Services. We offer you a full set of services to guide you through the broad range of requirements to obtain CE-marking, global device registrations, comply with the regulations, find GAPs in your processes and keep your system and registrations up to date. Within this process, our services support the Quality, Regulatory and Clinical Strategy:. Overall regulatory strategy support for market access. For mo...

2

Clinical Trial Support (pre- and postmarket) | Uncategorised

http://www.medq.eu/pre-and-post-market-clinical-consulting-services/clinical-regulatory-support

Clinical Trial Support (pre- and postmarket). Quality Consulting and Support. Clinical Trial Support (pre- and postmarket). Pre- and Post-market Clinical Trial Support. Provides support for your pre- and post-market trials. We will assist where needed in the preparation, conduct and management of your pre- and postmarket clinical trials according to the European Regulation and country specific requirements. In order to have your clinical trial successfully conducted, we support you with:. Atient Informat...

3

Authorized Representative | Uncategorised

http://www.medq.eu/authorized-representative-services

Clinical Trial Support (pre- and postmarket). Quality Consulting and Support. In accordance with t. He European Medical Device Directives, a manufacturer who places a device on the European market under his own name and does not have a registered place of business in the EU shall designate an authorized (AR) representative located in the EU which can act as the point of contact for the Competent Authorities and EU Comm. Liaison between legal manufacturer and Authorities. Vigilance and Safety Reporting.

4

Regulatory Consulting | Uncategorised

http://www.medq.eu/pre-and-post-market-clinical-consulting-services/regulatory-consulting-services

Clinical Trial Support (pre- and postmarket). Quality Consulting and Support. Consultants B.V. provides guidance and support according to the relevant European Medical Device Regulations by providing the following services. Liaison for Notified Body, Competent Authority and EU Commission. Determine Medical Device Classification. Prepare / review Technical Documentation. Prepare / review risk analysis according to EN ISO 14971:2012. Prepare / review Essential Requirements Checklist.

5

Quality Consulting and Support | Uncategorised

http://www.medq.eu/pre-and-post-market-clinical-consulting-services/quality-consulting-services

Clinical Trial Support (pre- and postmarket). Quality Consulting and Support. Quality Consulting and Support. Provides support to client’s Quality Management System (QMS) to implement or enhance the QMS for compliance with applicable regulations by providing the following services:. Support/guidance and/or maintenance of the QMS according to ISO13485 / 21CFR part820 (QSR) / CMDCAS / RDC 16 by means of:. QMS ISO 13485 / CMDCAS and/or RDC 16 certification as well as 21 CFR Part 820 (QSR) compliance.

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MedQ | Full Service CRO for Medical Device Startup Companies | MEDQ

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