About Me
ABOUT US
We can help you Fast-Track your medical device to market with the implementation of a ISO13485:2016
Quality Management System
24+ Years Experience
Writing and implementing hundreds of quality system documents including Quality Manuals, Procedures, SOPs, Forms, and Training Materials
Awards
Won Corporate Quality Award for site with most improved quality results
Versatile
Worked with Quality Systems for many types for classifications of medical devices from implantable, to medical instruments, to PPE.
Most start-up medical device companies are focused on developing their products and manufacturing capability and seldom have the time or resources to fast track the development, implementation, and certifcation of the required ISO 13485 Quality Management System.
This is where we can help, by using our extensive and proven experience in creating documentation templates which can easily be customized for your business and medical device.
This will enable you to fast track your QMS implementation by using the high-quality information we provide. Our QMS document templates provide the foundation for the ISO 13485 and US FDA 21 CFR Part 820 Quality System Regulation. We can then work with you to complete those procedures that will be specifc to your device and manufacturing processes, or you can decide to complete them yourself.
These days there are two main ways that start-up medical device companies implement their ISO 13485:2016 Quality Management System. They either hire, hopefully experienced and capable QA team members and if they have time and resources, they can carry out the complete design, documentation and implemention themselves;
or;
they use a consultant that has available the foundation of the documented QMS availabe as templates.
This later method can save time and provide you with proven documentation and experienced guidence throughout the implemention process from start through to certifcation.
Our experienced professionals along with our available documentation packages (and if you need it) consultation and training on the implementaion of your quality system, can help you safe time and money. This will help mitigrate the risks and headaches of start up and certification and let you focus on your product readiness.
Fast Track Your ISO 13485 Certification
Choose a FREE option that is right for your organization.
Brian Newbery
Founder and senior consultant at QMS Consultants, Asia
Brian Newbery is a professional quality management consultant with 24 + years of experience as a quality system leader in the medical device industry, both in North America and Asia.
He is a graduate in Mechanical Engineering with experience in manufacturing, R&D and quality. Before founding Fast-Track QMS Consultants, he was a senior manager at several medical device companies, including Director of Quality and Regulatory Management at a leading multi-national healthcare products and medical device company.
His Quality Management System experience and expertise covers all areas of developing, implementing, and maintaining a quality and regulatory management system that meets the ISO 13485:2016, US FDA and many other global requirements and certifications. This includes developing complete ISO 13485 quality systems, maintaining and improving those systems, training employees, as well as leading internal audits and hosting audits from International Certification Bodies and FDA.
Implementation Products and Consultation
Free Fast Track Planning Kit
Our free fast track planning kit is for businesses that have not started the planning or implementation of their quality management system.
Free ISO 13485 Gap Analysis
Our Free ISO 13485 Gap Analysis is for organizations that may have already started the development and implementation of their manufacturing capability and their quality management system
Consulting Services
Focus in on the areas of your quality management system that need the help to complete your implementation and achieve certification.
ISO Implementation Product Bundles
Successful ISO 13485 implementation and certification.