Quality System and
Risk Management Consulting
Quality is the Bedrock of Any Medical Device Organisation
Assembling a new quality management system from scratch is our specialty. No cookie-cutter solutions! We take the time to learn about your company, on or off-site, and customise our services to your specific requirements. We also help bigger organizations manufacture and smaller companies outsource manufacture. We convert non-medical QMS to medical and fill holes in current systems.
Also, Access-2-Healthcare was part of the TC210 teams actively developing and writing ISO13485 and ISO14971 standards, and has extensive expertise in medical technology production and commercial situations.
Quality Solutions That Solves Various Quality Challenges
Quality Management System
Plan, Do, Check, Act!
We design and help you implement a solid Quality Plan that will sustain for the long term:
Design > Build > Deploy > Control > Measure > Review > Improve
We help you from Ground Zero, and up to the point when the certificate hangs on your wall
- FDA Title 21, Section 820 Quality Systems Regulation (QSR)
- IMDRF Medical Device Single Audit Program (MDSAP)
- various Good Distribution Practices (GDP) requirements in the APAC region
Gap Analysis & Remediation
What is the purpose of highlighting issues without offering solutions?
We collaborate closely with your quality team to resolve difficulties and establish effective and sustainable solutions, resulting in the development of a robust quality system that is 100 percent compliant.
We do not only have fancy checklists!
We conduct a top-to-bottom audit of your organization to identify symptomatic and systemic weaknesses.
Determine the organization’s basic difficulties and resolve them at their source.
Competence Development & Inspection
The organisation got to perform when it needs to!
- We will teach and assist you on audit/inspection preparedness, providing subject matter knowledge and best practices, whether for certification or an inspection.
Way beyond Preaching!
We offer on-site and off-site customized training to corporate staff on all quality themes, QMS education, and quality strategy creation.
What Sets Us Apart?
We don't just follow the standards - we write them!
With years of practical expertise in medical technology production and commercial settings, we were engaged in the real ISO13485 and ISO14971 standard development and drafting processes.
This knowledge enables us to easily design and implement any quality management system for any size firm producing any kind of medical equipment.
As the specification creator and contributor to the actual standards, we are in a unique position to bring value to any organization. We are able to set up your quality management system due to our capacity to precisely and rapidly examine and assess the status of the organization, allowing us to properly scope the QMS implementation.