Medical Device ISO 13485 Consultation Support
If you are providing medical devices or providing components or services to the medical device industry, you must be certified to ISO 13485. ISO 13485 specifies requirements for a quality management system that can be used by any organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services. There are many different requirements based on the type of device or service offered. Your Quality Solutions ISO 13485 consultant will guide you through the process of documenting, implementing, and managing your system.
NQA 1 Compliance
For companies seeking NQA 1 compliance, we offer a complete set of services including documentation support. You can avoid the common pitfalls in integrating your ISO 9001 system with your NQA 1 system by working with one of our professional consultants.
Additional Training & Support
When needed, these additional ISO training and support services are offered:
- Production part approval process
- Advanced product quality planning
- Failure mode effects analysis
- Balanced scorecards, KPIs and corporate metrics
- Process management
- Internal auditing (conducting process audits)
In addition to our impressive ISO consulting services, Quality Solutions offers complimentary management consulting services.
Our additional services include:
- Assistance in developing business plans
- Information Systems policy and procedures
- Customer satisfaction surveys
- Internal audit training and assessments