[vc_row full_width=”stretch_row_content” full_height=”yes” content_placement=”middle” parallax=”content-moving” css_animation=”bottom-to-top” leaf_row_scheme=”0″ css=”.vc_custom_1652436317898{padding-right: 10% !important;padding-left: 10% !important;background-image: url(https://www.access2hc.com/wp-content/uploads/2022/05/istockphoto-1187679035-612×612-1.jpeg?id=8956) !important;}”][vc_column][vc_custom_heading text=”Maintaining Your Organisational Agility” font_container=”tag:h1|text_align:left|color:%23ffffff” use_theme_fonts=”yes”][vc_custom_heading text=”Quality System and Risk Management Consulting” font_container=”tag:h2|text_align:left|color:%23ffffff” use_theme_fonts=”yes”][/vc_column][/vc_row][vc_row full_width=”stretch_row_content” full_height=”yes” content_placement=”top” parallax=”content-moving” css_animation=”bottom-to-top” leaf_row_scheme=”0″ css=”.vc_custom_1652436335699{padding-right: 10% !important;padding-left: 10% !important;background-image: url(https://www.access2hc.com/wp-content/uploads/2022/05/christian-wiediger-EGO_412b7oo-unsplash-1-scaled.jpg?id=8957) !important;}”][vc_column width=”1/2″][/vc_column][vc_column width=”1/2″][vc_custom_heading text=”Quality is the Bedrock of Any Medical Device Organisation” font_container=”tag:h1|text_align:left|color:%23ffffff” use_theme_fonts=”yes”][vc_column_text]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.[/vc_column_text][/vc_column][/vc_row][vc_row full_width=”stretch_row_content” full_height=”yes” content_placement=”middle” parallax=”content-moving” css_animation=”bottom-to-top” leaf_row_scheme=”0″ css=”.vc_custom_1655529538876{padding-right: 10% !important;padding-left: 10% !important;background-image: url(https://www.access2hc.com/wp-content/uploads/2022/06/61ef39e6984858160159.jpg?id=9674) !important;}”][vc_column width=”7/12″][vc_custom_heading text=”Seamless Risk Integration” font_container=”tag:h1|text_align:left|color:%23ffffff” use_theme_fonts=”yes”][vc_column_text]We assist in establishing the risk management feedback loop with your design and ensuring the risk controls translate to the necessary design changes.[/vc_column_text][/vc_column][vc_column width=”5/12″][/vc_column][/vc_row][vc_row css_animation=”fadeInUp” leaf_row_scheme=”0″ css=”.vc_custom_1652436381682{padding-top: 90px !important;padding-right: 10% !important;padding-left: 10% !important;background-color: #ffffff !important;background-position: 0 0 !important;background-repeat: repeat !important;}”][vc_column css_animation=”none”][vc_column_text]

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We can go fully remote! See how we fully deployed a certified quality management system from our case study.

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QUALITY SOLUTIONS THAT SOLVES VARIOUS QUALITY CHALLENGES

             

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[/vc_column_text][vc_tta_accordion c_icon=”triangle” active_section=”0″ css_animation=”none” collapsible_all=”true”][vc_tta_section title=”Quality Planning” tab_id=”1596017015125-52c4bb3b-c3e7″][vc_column_text]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[/vc_column_text][/vc_tta_section][vc_tta_section title=”Establish Quality Management Systems” tab_id=”1596017015126-9062ecd7-9f54″][vc_column_text]We help you from Ground Zero, and up to the point when the certificate hangs on your wall

– ISO13485

– 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[/vc_column_text][/vc_tta_section][/vc_tta_accordion][vc_empty_space][vc_empty_space height=”40px”][vc_column_text]

[/vc_column_text][vc_tta_accordion c_icon=”triangle” active_section=”0″ css_animation=”fadeInUp” collapsible_all=”true”][vc_tta_section title=”Quality System Remediation” tab_id=”1596017237716-b689f3e6-b98f”][vc_column_text]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.[/vc_column_text][/vc_tta_section][vc_tta_section title=”Quality System Assessment, Gap Analysis” tab_id=”1596017237717-dd46796b-a2a2″][vc_column_text]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.

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[/vc_column_text][vc_tta_accordion c_icon=”triangle” active_section=”0″ css_animation=”fadeInUp” collapsible_all=”true”][vc_tta_section title=”Implementation Readiness” tab_id=”1596017541763-82e41fb2-6948″][vc_column_text]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.[/vc_column_text][/vc_tta_section][vc_tta_section title=”Quality Competence Development” tab_id=”1596017541763-87214680-8444″][vc_column_text]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.[/vc_column_text][vc_empty_space][/vc_tta_section][/vc_tta_accordion][vc_empty_space][/vc_column][/vc_row][vc_row gap=”30″ css_animation=”fadeInUp” leaf_row_scheme=”0″ css=”.vc_custom_1652436434858{padding-right: 10% !important;padding-left: 10% !important;}”][vc_column css=”.vc_custom_1647680828482{border-radius: 2px !important;}”][vc_column_text]

[/vc_column_text][vc_column_text]Experience our Made-to-Measure Quality Consulting Solution.  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. Because of our extensive product knowledge in the medtech industry, we can understand the organization needs very quickly, customize the scope faster than most, with very little wastage.  This translate to a more efficient pathway to establish and effective quality management system and gain the certification that you need[/vc_column_text][vc_empty_space][vc_column_text]

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We can go fully remote!

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.

We’ve even certified businesses that felt this was impossible.

See how we fully deployed a certified quality management system from our case study

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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.

[/vc_column_text][/vc_column][/vc_row][vc_row css_animation=”fadeInUp” leaf_row_scheme=”0″][vc_column][vc_empty_space height=”40px”][vc_btn title=”CONTACT US” color=”warning” align=”center” i_icon_fontawesome=”fas fa-envelope-open” add_icon=”true” link=”url:mailto%3Ahelpme%40access2hc.com%3Fsubject%3D|target:_blank”][vc_empty_space height=”50px”][/vc_column][/vc_row][vc_row css_animation=”fadeInUp” disable_element=”yes” leaf_row_scheme=”0″][vc_column width=”1/3″][vc_column_text]Quality Planning

 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

[/vc_column_text][/vc_column][vc_column width=”1/3″][vc_column_text]Quality System 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

[/vc_column_text][/vc_column][vc_column width=”1/3″][vc_column_text]Inspection Readiness

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.

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[/vc_column_text][vc_empty_space][/vc_column][/vc_row][vc_section disable_element=”yes”][vc_row gap=”2″ disable_element=”yes” leaf_row_scheme=”0″][vc_column][/vc_column][/vc_row][/vc_section][vc_row disable_element=”yes” leaf_row_scheme=”0″][vc_column][vc_separator color=”turquoise” style=”dashed”][vc_separator color=”turquoise” style=”dashed”][/vc_column][/vc_row][vc_row disable_element=”yes” leaf_row_scheme=”0″ css=”.vc_custom_1642307067173{background-color: #ffffff !important;}”][vc_column][vc_tta_accordion c_icon=”triangle” active_section=”0″ css_animation=”fadeInUp” collapsible_all=”true”][vc_tta_section title=”Risk Based Approach Integrated Package” tab_id=”1593486439778-6498ca9b-8d08″][vc_row_inner][vc_column_inner width=”1/6″][vc_single_image image=”7869″ img_size=”250×250″ alignment=”center”][/vc_column_inner][vc_column_inner width=”5/6″][vc_empty_space height=”10px”][vc_column_text]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.[/vc_column_text][/vc_column_inner][/vc_row_inner][vc_column_text]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[/vc_column_text][/vc_tta_section][vc_tta_section title=”Software Validation Compliance Package” tab_id=”1593486438732-478fe31d-66a6″][vc_row_inner][vc_column_inner width=”1/6″][vc_single_image image=”7829″ img_size=”250×250″ alignment=”center”][/vc_column_inner][vc_column_inner width=”5/6″][vc_empty_space height=”10px”][vc_column_text]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?’[/vc_column_text][/vc_column_inner][/vc_row_inner][vc_column_text]– 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.[/vc_column_text][/vc_tta_section][vc_tta_section title=”Regulatory Requirement Compliance Package” tab_id=”1593486425900-5f6235ca-7f89″][vc_row_inner][vc_column_inner width=”1/6″][vc_single_image image=”6234″ img_size=”250×250″ alignment=”center”][/vc_column_inner][vc_column_inner width=”5/6″][vc_empty_space height=”30px”][vc_column_text]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?[/vc_column_text][/vc_column_inner][/vc_row_inner][vc_column_text]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.[/vc_column_text][/vc_tta_section][vc_tta_section title=”Supplier Controls Compliance Package” tab_id=”1593486425939-95b796b6-4911″][vc_row_inner][vc_column_inner width=”1/6″][vc_single_image image=”7835″ img_size=”250×250″ alignment=”center”][/vc_column_inner][vc_column_inner width=”5/6″][vc_empty_space height=”30px”][vc_column_text]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.[/vc_column_text][/vc_column_inner][/vc_row_inner][vc_column_text]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).[/vc_column_text][/vc_tta_section][/vc_tta_accordion][vc_separator color=”turquoise”][vc_empty_space][vc_column_text]

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Research to Development Mentorship

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Investment Referral

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Medical Technology Design & Development

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Quality Systems Consulting

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Clinical site support

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Manufacturing scale up and set up

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Supplier Control Support

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Go-To-Market Strategy Services

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 Full Suite Regulatory Services

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Business Due Diligence

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Licensing holding

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Regional Sales / Tech Service Hub

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