(312) 207-5800 REQUEST INFORMATION WHAT WE DO OUR COMPANY RESOURCES CONTACT US Medical Device Testing Services Arbour Group assists medical device companies with compliance related to the requirements of the FDA and other international regulatory agencies as well as the guidelines contained in ISO 13485, Quality Management Systems, ISO 14971 and Application of Risk Management to Medical Devices. We help clients achieve a culture of compliance that raises quality levels, reduces risk and costs as well as increase shareholder value. Home Industry Medical Devices Quality You Can Trust The testing of medical devices to meet the standards of regulatory agencies requires the expertise of an industry leader. Arbour Group helps organizations worldwide deliver on compliance through core competencies including: Software Validation and Testing Policies & Procedural Controls Quality Agreements Predicate Device Research Our expert teams will ensure that your medical device meets the stringent requirements set forth by the FDA and other regulatory agencies. Why We're Better Arbour is dedicated to bringing your organization all of the necessary tools for compliance. Our years of experience coupled with our dedication to service ensure that your organization will succeed. We believe in a holistic approach to compliance, delivering extensive regulatory expertise and proven methodologies to help you achieve your goals. Our proven methodologies and best practices deliver in-depth regulatory expertise globally in the following areas: Software Validation and Testing 510(k) Validation & Verification Data Center Compliance Sarbanes-Oxley Compliance 21 CFR Part 11 Assessment Predicate Device Research IT Services Analysist & Vendor Audit Compliance Analytics Embedded Software Testing Quality Assurance 4 Application Software Testing Request More Information This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. Case Study Global Medical And Dental Products Corporation View Case Study WHAT OUR CLIENTS THINK The regulatory assistance provided by Arbour Group has enabled us to enhance our compliance profile with life sciences customers. Their Managed Services for software development and quality assurance play a key role in controlling business risk and reducing costs. Chief Technology Officer at a rapidly growing medical information company Products SAP S/4HANA SAP Business One SAP Business ByDesign Oracle E-Business Suite Oracle ERP Cloud JD Edwards QAD MS Dynamics ProcessForce NetSuite Validation Infor ERP Validation Services Audits Validation & Compliance Research Managed Services Testing & Certification Quality Assurance Regulatory Education & Training Digital Compliance Services Digital Transformation Services Testing & Certification Application Software Testing Embedded Software Testing Enterprise Software Testing Software Certification Industry Pharmaceuticals Medical Devices Biotechnology Diagnostics Arbour Group Warranted regulatory solutions, your partner in compliance. Request Information (312) 207-5800 One Parkview Plaza, Suite 660 Oakbrook Terrace, IL 60181 All Rights Reserved ©2021 Arbour Group LLC. | Sitemap × We use cookies to help us offer you the best online experience. By continuing to use our website or closing this window, you're providing consent regarding cookies. If you want to learn more read our Privacy Policy.