Maintaining Your Organisational Agility
Quality System and Risk Management Consulting
Quality is the Bedrock of Any Medical Device Organisation
We provide Made-to-Measure Quality Consulting solutions, establishing the quality management system from scratch. No cookie-cutter solutions! We take the time to understand your organisation, on- or off-site, providing a scope of work that is tailored to your exact needs.
Seamless Risk Integration
We assist in establishing the risk management feedback loop with your design and ensuring the risk controls translate to the necessary design changes.
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
Establish Quality Management Systems
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
Quality System 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.
Quality System Assessment, Gap Analysis
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.
Quality Competence Development
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?
Access-2-Healthcare has connections with different types of investors, all with healthcare and/or MedTech mandates. We understand each investor’s needs well and can tap on a large database of MedTech companies, a list we have accumulated over years of good relationships with founders and CEOs.