Life Science Specialists
Get access to SimplerQMS Life Science Specialists. We have 30+ years of experience implementing validated software solutions.
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Moving Away From Manual Processes
From many years of experience in the Life Science industry, we know that manual documentation processes and paper records can slow down innovation and growth. We are also aware that implementing and running validated IT-systems is not a core competency at Life Science companies.
Therefore, we applied our 30+ years of experience, to building and implementing the SimplerQMS Solution in Medical Device, Pharma, and Biotech Companies.
Fast and Proven Implementation Method
Our proven implementation method will help you reap the benefits of an eQMS in a matter of weeks.
We are ready to help, no matter if you are about to build your Quality Management System or if you already have a QMS in place. We created a fast and proven process for onboarding Life Science companies, including full system implementation and training of users in a matter of 5 – 6 weeks. Thanks to our fully validated software and ready-to-use life science modules our main focus is on training your users.
Work Efficiently and Stay Compliant
Maintenance of certifications and compliance with the latest Life Science regulatory standards is key to our company’s and our customer’s success.
SimplerQMS, as an organization, is ISO 13485:2016 certified, which guarantees a high level of quality of our products and services. We provide an eQMS solution that aligns with the latest Life Science regulatory requirements such as GxP, ISO 9001, CFR 21 Part 11, 210, 211, 820, EU GMP Annex 11, ISO 13485, ICH Q10, EU MDR and IVDR, and more.
Our organization and our customers have passed hundreds of audits and inspections by the regulatory authorities. Through these audits, we gained a deep understanding of what is needed for Life Science organizations to demonstrate regulatory compliance while working more efficiently.
Download our ISO 13485:2016 Certificate here.
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Meet the Founders
Allan Murphy Bruun
Co-founder & Business Development Director
Before founding SimplerQMS in 2017, Allan was a Business Systems Consultant at Ambu, a Danish medical device company with more than 2.000 employees worldwide. He was responsible for implementing validated business applications in compliance with ISO 13485:2016 and FDA 21 CFR Part 11 in the global organization.
He has also founded Aidcube, a Digital Therapeutics Platform used by more than 2.000 patients with COPD and Heart Disease at rehabilitation programs run by hospitals such as UCSF San Francisco and Clinics in the Capital Region of Denmark.
Jacob Sjørslev Hyrdum
Co-founder & CEO
Prior to founding SimplerQMS, Jacob was the CIO at Ambu, a Danish medical device company with more than 2.000 employees worldwide. He was responsible for Ambu’s international IT organization including all systems such as Global ERP, PLM, CRM, BI, cloud, outsourcing of services, compliance, and validation.