Services
Serving all of your Digital Quality Business Needs
Quality Management Systems (QMS) Development and Certification
Whether you are looking to build a new QMS for your company's digital health products or technology solutions, or updating your existing QMS to support digital, we can help design, build and implement the elements of your QMS, including policies, procedures, training & education and certification of your QMS. In addition we will work with your technology organization and business leaders to design the right IT strategy to support your QMS needs.
Training and Education
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Some of the biggest challenges companies face when building their quality programs for digital products is learning the digital ecosystem and associated health authority requirements. We can help you navigate by delivering training and education packages, including live webinars, online training, and training materials. In addition we offer services in delivering training for your newly built or existing QMS elements.
Digital Strategy and Transformation
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In order to stay pace with industry 4.0 and increasing needs for digitization to meet the current and future supply chain challenges and needs, it is important that your company's quality strategy and plan includes transforming your business from disparate and manual processes and data sources to a highly integrated, automated digital quality environment. Whether it be evaluating your existing processes and systems and developing a strategy to move to a digital ecosystem or working with your technology teams to build out digital product "factories" we are best served to help you with this transformation.
Audit/Inspection Readiness and Response
One key factor in establishing your company's Digital Quality strategy is ensuring your people, processes and technology are audit and inspection ready. We provide audit planning support, mock audit support and remediation services (i.e. EU MDR, etc.). In addition, we can provide any support to facilitate correspondence with health authorities in regards to any inspection related inquiries.
Ad Hoc/On Demand Research and Consulting
$100
30 Minute Quick Consult
Do you ever just need an easy answer to a regulatory, compliance or quality question and don't have the time to do the research? We are here to help with these quick consults to get the answers you need quickly to accelerate your day.
$200
60 minute Quick Consult
Longer sessions can be held to provide an opportunity to tackle more complicated questions, or provide input and/or reviews on SOPs, presentations, white papers, etc. In addition, these sessions are optimal for regulation review and interpretation.