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The CRO Group | Global Regulatory Consulting

A leading global consulting organization specializing in SaMD 510(k) and CE Marking, ISO 13485:2016, MDSAP and upcoming EU MDR

http://www.crogroup.com/

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2 mhealth
3 otc products
4 safety critical systems
5 services
6 certifications
7 electrical/emc
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10 clinical studies
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The CRO Group | Global Regulatory Consulting | crogroup.com Reviews

https://crogroup.com

A leading global consulting organization specializing in SaMD 510(k) and CE Marking, ISO 13485:2016, MDSAP and upcoming EU MDR

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us.crogroup.com us.crogroup.com

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歡迎光臨我們的網站 |

Clearances & Approvals 產品批准和認證. Auditing & Training. Our Partners and Consultants. 90 天完成ISO 13485 認證. Custom Auditing and Training. Achieve Your Clinical Endpoints the First Time. CRO Group確保各項服務,都遵從根最新的 優良的自動化生產規範 ,電子記錄與電子簽證. 規範 Part 11 和臨床信息要求等法律法規的要求。 请在 最新技术 and 开发技术 一栏里,查看我们最近完成的合作项目内容. 变化 ,ISO 13485:2012, ISO 14971:2012, IEC 62304 (使用Agile/SCRUM开发软件),还是加拿大医. The CRO Group, Inc. Designed by Elegant Themes.

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Clearances & Approvals Sub Clinical Trials | The CROGroup

http://crogroup.com/clearances-approvals/clearances-approvals-sub-clinical-trials

Auditing & Training. Clearances & Approvals. With partners and affiliates located on both coasts in the USA, Canada, and Europe, we are in the unique position of offering multi-site investigation planning, management, and compliance services to support your 510(k), PMA, and EU Design Dossier or Technical File. Compliance monitoring and auditing. For your global multi-center trials supporting device registrations, advertising claims and or capturing the all important government reimbursement.

2

Clearances & Approvals Sub Software | The CROGroup

http://crogroup.com/clearances-approvals/clearances-approvals-sub-software

Auditing & Training. Clearances & Approvals. The FDA now recognizes international standards which may be used to support CE Marking, The CRO Group now offers a combined software compliance support service. We are conversant in the latest languages including Visual C , C#, and Visual Basic, as well as Microsoft.net development platforms, as well as the vintage languages. There are now three methods of supplementing your 510k submission when software is involved:. Contact us by clicking here.

3

Auditing & Training | The CROGroup

http://crogroup.com/auditing-training

Auditing & Training. Clearances & Approvals. Offers auditing services to companies in the medical device, biotechnology, and IVD industries to comply with FDA-QSR, Part 11, ISO 13485, Canadian MDR (CMDCAS), and EU MDD or IVDD regulations, as well as related to clinical trials. Our consultants don’t just audit, we provide value-added post-auditing services, assisting management in not only achieving conformity, but doing so swiftly and in line with your budget. 8211; Glen Emelock, Sr. Partner. When you ar...

4

Digital Marketing | The CROGroup

http://crogroup.com/digital-marketing

Auditing & Training. Clearances & Approvals. The marketing and online advertising of both OTC (Over The Counter) and Rx Only (Prescription Use Only) Medical Devices have come under increased FDA scrutiny over the past few years. With recent reactive FDA regulation interpretations, and guidance’s enforced as regulations, advertising and marketing in print and broadcast media, online, and especially via social networking all are being FDA monitored like never before. How We Can Help. The CRO Group, Inc.

5

Clinical Studies | The CROGroup

http://crogroup.com/clinical-studies

Auditing & Training. Clearances & Approvals. Enhanced Your Next Clinical Studies. Offers a robust suite of Clinical Trial Services to support the needs of medical device developers as well as other trial sponsors from premarket submissions to post-marketing advertising campaigns, and virtually everything in-between. Our Clinical Trial Service menu starts with study designs resulting in plans and protocols with endpoints, methodology, and statistical considerations that fit your budget and business goals.

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Clearances & Approvals 產品批准和認證. Auditing & Training. Our Partners and Consultants. 90 天完成ISO 13485 認證. Custom Auditing and Training. Achieve Your Clinical Endpoints the First Time. CRO Group確保各項服務,都遵從根最新的 優良的自動化生產規範 ,電子記錄與電子簽證. 規範 Part 11 和臨床信息要求等法律法規的要求。 请在 最新技术 and 开发技术 一栏里,查看我们最近完成的合作项目内容. 变化 ,ISO 13485:2012, ISO 14971:2012, IEC 62304 (使用Agile/SCRUM开发软件),还是加拿大医. The CRO Group, Inc. Designed by Elegant Themes.

eisnersafety.com eisnersafety.com

Eisner Safety Consultants » Affiliates

http://www.eisnersafety.com/about_us/affiliates

Engineering your products through the 21st Century. Navigating The Safety Agency Certification Maze. Current IEC 60601-1 Based Standards. Draft IEC 60601-1 Based Standards. EU Articles & Information. List of Harmonized Standards for the MDD. Technical File Before CE Marking. Global Medical Device Regulatory & Standards Updates. IEC 60601-1-9 required for Brazil Near End of 2016. Need Help with Your Medical Device – See You in SF Bay Area End Apr & San Diego Early May ’16. Current IEC 60601-1 Standards.

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Auditing & Training. Clearances & Approvals. Zero to ISO 13485 in 90 Days. Custom Auditing and Training. Achieve Your Clinical Endpoints the First Time. For more information, click here. The CRO Group provides consulting services acting as part of your engineering, clinical, quality and regulatory team. Please find our recent technologies and techniques along with our recent devices that we have worked with below. For more information on our Consulting Services click here. For more information click here.

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