QUALITY IS THE BEDROCK OF ANY MEDICAL DEVICE ORGANISATION
We are in the actual standards development and drafting process for ISO13485 and ISO14971 and with years upon years of practical experience in medical technology manufacturing and commercial environments.
How does that translate to your results?
Experience our Made-to-Measure Quality Consulting Solution. No cookie-cutting! We spend the time to understand your organisation–on or off site-and provide a scope of works that is tailored to your exact needs
Access-2-Healthcare promotes the concept of remote consulting to deliver our work anywhere in the world and to fit with the current situations – we deliver projects remotely very well and across language barriers
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’s the point of pointing out the problems without giving the solutions?
– We work closely with your quality team for resolution of issues and to develop effective and sustaining strategies, build a strong quality system that’s 100% compliant
Not just fancy checklists
– We run through your entire orgnisation top to bottom to find symptomatic and systemic gaps.
– Discover the underlying challenges in the organisation and solve it at the root.
COMPETENCE DEVELOPMENT & INSPECTION
The organisation got to perform when it needs to!
– Whether for a certification or an inspection, we will train and guide you on audit/inspection readiness, provide subject matter expertise and best practices.
Way beyond Preaching
– We provide bespoke relevant company personnel training on all quality topics, QMS education and quality strategy development on and off site.
SMART QMS PACKAGES
QMS Packages as an initiative to provide top-quality compliance results by top-quality experts for small to medium sized medical technology companies who KNOW what they need.
Specific, Measurable, Actionable, Realistic, Time-bound – Available for 4 critical aspects in Quality Management Systems.
Keep hearing about how the risk-based approach is the biggest impact in ISO13485:2016? Which areas in my quality management system needs it? How to incorporate? Are risk scores and assessments necessary? Do you get plagued by these questions?
Our Risk Based Approach Integration package helps to relieve this pain point effectively and cost-effectively.
Update all the SOPs with necessary statements to address the risk based approach. Which ones?
– system related (CAPA, training, auditing, NC systems)
– process related (design/development, supplier controls, manufacturing, services)
– product related (risk analyses, FMEAs, FTAs, usability)
– and the interaction between the above
Include risk scoring or risk assessments as required. Scope includes all product realisation activities, which is already a requirement since 2003.
Organise virtual training (2 sessions – one for updated procedures training, one Q&A post implementation) for your organisation
The new software validation requirements in ISO13485:2016, especially for quality-systems related and process-related software, adds a new dimension to software validation.
Perhaps you are caught out, or having validated some software, but not the others, and certainly not the ones that you have not ‘discovered’? Then there are questions about ‘how much should I do to validate these software?’, what if my vendors don’t have these information?’
– Pre-Work Package (optional) – We give you directions to go ‘software hunting’ – where can these software be? Which to safely exclude? This saves your time of asking each other the question ‘where do we start?’
– Assess Validation Requirement – as well as the extent of validation if you collect all the software. This includes disposition for COTS (commercial-off-the-shelf) software.
– Train the Organisation on Validation Requirements – After knowing what to validate, we can help to communicate the requirements and the action plan together with you – virtually, or on-site.
– Provide Validation Plan – a master validation plan (MVP) based on your company-specific situation, to give clear and unambiguous guidance for your organisation. We also provide templates to validation protocols and reports.
– Remote/on-site Process Audit – we review and assess if the software validation requirement has been met. Complete with audit report.
The term ‘regulatory requirements’ appeared 44 (!) times in the ISO13485:2016. With all these regulations around the world changing and changing, how would any organisation keep up? Would you get caught out and not be able to ship product out or to that regulated country? How do we ensure we don’t miss out?
It’s certainly not by placing the words ‘regulatory requirements’ all over your organisation’s procedures!
– We revise your organisation’s documentation to: Include in design & development, design input, design V&V Add into management review
– Add in to change control form Document/records control
Train the company (virtual) on these updated procedures
– Provide regulatory strategy document specific to your organisation.
– How to scan for global regulatory requirement to keep the documents updated earlier, up-to-date.
– How to assess and communicate the impact of regulation changes to your organisation, and drive the resulting action plan with other stakeholders
In addition, we provide:
– The updated regulatory requirement for pre, post, QMS, clinical ( per country, yearly subscription) – far better and quicker than any other regulatory source.
– Regulatory update sent directly to you, within 7 working days of its release, including a summary impact assessment.
The strengthening of purchasing controls all round in ISO13485:2016 is one of the key changes to the Standard. More emphasis is placed on the formality of supplier relationships through written agreements, and extending the scope of the standard to all parts of the supply chain.
How do we know which suppliers to control? To what extent? Do we have to audit every one of them? How do we convince them to sign a documented agreement with us? Should the business agreement be different from the quality agreement? If suppliers do not perform, how do manage them?
– Risk based assessment of suppliers – Once the supplier profiles are collected, the supplier assessment report would have the suppliers having its risk and criticality tied to your products and/or processes, and thus have various levels of control to match your organisations’ resources. (Pre-requisite is that the supplier list and descriptions are exhaustive and completed)
– Supplier agreement template – includes all of the necessary requirements including supplier changes notification processes, supplier performance, quality metrics, roles and responsibilities in post-market surveillance, customised. All you need to do is insert your organisation name, address and signatories. (Free: valuable advice on how to engage with difficult suppliers who are resistant to signing an agreement)
– Provide supplier control plan – which to on-site audit, which to desk audit, which to inspect; how often, corrective actions if there are non-compliance issues. (Note: suppliers must have completed the signing of the written agreement).