HighRely Medical Devices - Compliance to FDA QSR, FDA 510(k)

	Medical 510(k) Solutions
	Medical Device Solutions

HighRely's primary expertise is on custom software engineering for medical products. We have extensive skills in developing software that integrates with custom hardware in all stages of product life cycle development. Our list of clients' projects range in size from small components of a larger project to complete full turnkey Medical Software development and integration.

Are you new to the FDA Approval processes for embedded medical devices? HighRely’s managers & engineers have helped customers expedite time to market and reach FDA approval successfully, the first time. JumpCert 510(k) will ensure that your project is on schedule, within budget and achieves successful certification.

HighRely’s FDA Compliance Engineering & JumpCert 510(k) Services Covers:

Software Design and Implementation
Software Testing, Quality Assurance, & Validation
Project Management
Software Design and System Architecture
Software Development Processes and Checklists
Requirements Analysis, Development and Management
SEI CMMI Capability Maturity Model
FDA 510(k) & PMA
21 CFR Part 820 - Quality System Regulation
21 CFR Part 11 - Electronic Records

HighRely Medical Devices services comply with the FDA's 510(k) and PMA requirements. HighRely's proven quality system is compliant with both the FDA's 21 CFR Part 820, and the ISO/DIS 13485 standards for quality systems.

Contact info<at>highrely-dot-com for more information

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Medical 510(k) Solutions

Medical Device Solutions