Providing consistently high quality patient products and services are the foundation to keeping people healthy and safe. From medical device production, to clinical services, to hospitals, we help organizations at every step in the medical supply chain improve operations and reduce risks. Our quality, health, safety and environmental management system consultants have the expertise to help you provide quality healthcare products and services with confidence.
We Know Your Industry
Our consultants have an average of over 25 years of real business experience to address the robust needs of our clients in the medical industry. We combine a thorough understanding of your needs and our specialized experience, to develop customized solutions that achieve real results.
Industry News
- Medtronic, NVIDIA to combine forces on AI devices, allowing users to create new software 03/21/2023The companies are working together to allow physicians and developers to build AI applications for Medtronic devices, beginning with the GI Genius endoscopy platform.
- Spine robot maker Accelus gains another FDA clearance 03/21/2023The company believes its Remi device, which works with several major imaging systems, can gain traction in the market with its portable design.
- Boston Scientific, Medtronic expected to quickly capture new atrial fibrillation market: analysts 03/21/2023The companies have acquired pulsed field ablation devices in recent years, but one surgeon told analysts he prefers Boston Scientific’s device as it doesn’t require general anesthesia, leading to faster patient turnaround.
- J&J’s Ashley McEvoy named chair of AdvaMed 03/20/2023McEvoy, who is J&J’s worldwide chairman of medtech, will lead the trade association’s board for the next two years.
Medical Solutions
Business Solutions
Management Systems
Auditing
Training
- ISO 9001:2015 QMS Fundamentals & Internal Auditor
- New Quality Manager
- Document and Record Control
- Writing Standard Operating Procedures
- ISO 9001:2015 QMS Fundamentals
- Five Why Technique and Corrective Actions
- Certification Process and Audit Preparation
- Context of the Organization & Interested Parties
- Risk Assessment and Controls
Resources
- U.S. Department of Health and Human Services (HHS)
- U.S. Occupational Safety and Health Administration (OSHA)
- U.S. Food and Drug Administration (FDA)
- Centers for Disease Control and Prevention (CDC)
- Medicare
- The Joint Commission
- Accreditation Commission for Health Care (ACHC)
- Healthcare Facilities Accreditation Program (HFAP)
- DNV GL Healthcare
- International Organization for Standardization (ISO)
- ASTM International
- American Hospital Association