Consulting Services for Medical Device Manufacturers and Healthcare IT Developer

WE HELP MEDICAL DEVICE MANUFACTURERS AND HEALTHCARE IT DEVELOPERS WITH REGULATORY COMPLIANCE, TECHNICAL STANDARDS AND CARE COORDINATION SOLUTIONS 

HiQ can provide independent consulting services to medical device manufacturers and healthcare IT developers for regulatory compliance, technical standards, and development of high-usability interoperability, clinical decision support and clinical quality analytics solutions. We offer this with the intention of the free market offering better medical device and software solutions to healthcare organizations!

HiQ developer consulting provides a unique combination of expertise with regulatory requirements, process standards and technical standards as listed below, with deep insight into the healthcare market and HiQ’s innovative and entrepreneurial company culture.

Regulatory Compliance Consulting 

•  FDA Medical Device GMP 
•  CE Mark Medical Device Directive & Regulations 
•  ONC HIT Certification Program
• Prevention of Information Blocking

Quality Management System Consulting 

•  ISO 9000:2015, ISO 9001:2015, ISO 9004:2018 
•  ISO 13485:2016 
•  ISO/IEC/IEEE 90003:2018 

Life Cycle Processes Consulting 

•  ANSI/AAMI/IEC 62304:2016 
•  ISO/IEC/IEEE 12207:2017 
•  ISO/IEC/IEEE 15288:2015 

Risk Management Consulting 

•  ISO 14971:2019 
•  ISO 31000:2018, ISO/TR 31004:2013, IEC 31010:2019, ISO 31022:2020 

CEHRT Referral Management / Care Coordination Solutions

• Referral order meta-data management
• Direct messaging and Query-Based HIE workflows
• HL7 C-CDA, CCDS, USCDI, specialty data

Schedule a Consultation

 

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HiQ developer consulting is provided entirely according to customized Statements of Work. We have extensive experience in analyzing prospective client requirements to create fixed-price proposals when appropriate, dating back to HiQ’s predecessor, Software Engineering Services, Inc. originally founded by Mike Schmidt in Silicon Valley in the 1990’s. However, HiQ does not provide the turnkey system and software engineering projects which SES was originally known for, but it continues the SES tradition of quality management, regulatory compliance and product strategy consulting.

We also welcome partnerships, particularly with HIT or healthcare services vendors, as may create mutually benefit and allow HiQ opportunities to focus on its core mission of assisting healthcare providers. HiQ has extensive experience in providing services in a manner complementary to HIT software support services, in the form of premium, value-added regulatory compliance services; such partnerships are contingent on ensuring HiQ’s primary role as an independent advocate for mutual clients and an effective framework for coordination and cooperation, such as via bi-directional support case escalation.