Business
Tue Apr 23,2019 10:00 am
Agatha Announces Strategic Partnership Agreement with Qualitiso for the Medical Device industry
Agatha Inc.
Tokyo, Japan, April 23rd, 2019 – Agatha Inc., a global leading provider of Quality and Content Management cloud service, Today announced that it has signed a partnership agreement with Qualitiso, a market leading provider of quality templates and consultancy for Medical Devices companies.
Tokyo, Japan, April 23rd, 2019 – Agatha Inc., a global leading provider of Quality and Content Management cloud service, Today announced that it has signed a partnership agreement with Qualitiso, a market leading provider of quality templates and consultancy for Medical Devices companies.
This partnership allows Agatha to provide standard modules meeting the Medical Device Industry’s document and international standard’s requirements out-of-the-box.
“A new regulation for medical device companies is coming into effect in Europe in May 2020 putting more controls around the regulatory, clinical and post-market surveillance processes. We are therefore seeing an increasing demand from the industry for an electronic solution to support the new regulations short term.” said Mr. Guillaume Promé, Chief Executive Officer at Qualitiso. “With Qualitiso document templates integrated into Agatha first-class leading document and quality product, we are providing the industry with a unique comprehensive packaged solution responding to the latest requirements in Europe”
Qualitiso provides a global set of document templates applicable to the Medical Device industry, matching the latest international standards applicable Worldwide (e.g. ISO 13485, ISO 14971, IEC 62304) and complying with the future European regulations applicable in May-2020.
“This partnership with Qualitiso allows us to bring our market leading cloud solutions to the medical devices organizations with standard modules that meet the market need out-of-the-box,” says Guillaume Gerard, Chief Operating Officer at Agatha. “Qualitiso strong business expertise and templates coupled with Agatha immediately available standard modules for quality, regulatory and clinical management will help medical device clients worldwide to ensure their compliance and streamline their document management and quality processes. We are very excited about this strategic partnership.”
ABOUT Qualitiso.
Qualitiso provides an intelligent set of templates and tools for medical device companies to set-up their quality system in accordance with the latest international standards and European regulations.
The templates can be automatically selected to match their specific business using intelligent wizards. https://www.qualitiso.com/
About Agatha, Inc.
Agatha, Inc. is a leading strategic software solutions provider to the health care and life sciences industry. Agatha is dedicated to helping the world’s Hospitals, biotechnology, pharmaceutical, contract research organizations and medical device firms optimize the management of their Quality, Regulatory and Clinical documentation and processes.
Agatha solutions are immediately available online, and compliant with applicable regulations (such as FDA 21 CFR part 11). Agatha’s clients are typically up and running in a few hours, greatly decrease their compliance risk, and reduce the time spent to manage their clinical, quality and regulatory documentation by 80% in average. Agatha is therefore the trusted partner of more than 100 hospitals, research centers, CROs, pharmaceutical companies and medical device companies worldwide. https://en.agathalife.com
Contact
Company: Agatha Inc.
Contact: Guillaume Gerard
Tel: +33 9 74 59 52 99
Email: info@agathalife.com
This partnership allows Agatha to provide standard modules meeting the Medical Device Industry’s document and international standard’s requirements out-of-the-box.
“A new regulation for medical device companies is coming into effect in Europe in May 2020 putting more controls around the regulatory, clinical and post-market surveillance processes. We are therefore seeing an increasing demand from the industry for an electronic solution to support the new regulations short term.” said Mr. Guillaume Promé, Chief Executive Officer at Qualitiso. “With Qualitiso document templates integrated into Agatha first-class leading document and quality product, we are providing the industry with a unique comprehensive packaged solution responding to the latest requirements in Europe”
Qualitiso provides a global set of document templates applicable to the Medical Device industry, matching the latest international standards applicable Worldwide (e.g. ISO 13485, ISO 14971, IEC 62304) and complying with the future European regulations applicable in May-2020.
“This partnership with Qualitiso allows us to bring our market leading cloud solutions to the medical devices organizations with standard modules that meet the market need out-of-the-box,” says Guillaume Gerard, Chief Operating Officer at Agatha. “Qualitiso strong business expertise and templates coupled with Agatha immediately available standard modules for quality, regulatory and clinical management will help medical device clients worldwide to ensure their compliance and streamline their document management and quality processes. We are very excited about this strategic partnership.”
ABOUT Qualitiso.
Qualitiso provides an intelligent set of templates and tools for medical device companies to set-up their quality system in accordance with the latest international standards and European regulations.
The templates can be automatically selected to match their specific business using intelligent wizards. https://www.qualitiso.com/
About Agatha, Inc.
Agatha, Inc. is a leading strategic software solutions provider to the health care and life sciences industry. Agatha is dedicated to helping the world’s Hospitals, biotechnology, pharmaceutical, contract research organizations and medical device firms optimize the management of their Quality, Regulatory and Clinical documentation and processes.
Agatha solutions are immediately available online, and compliant with applicable regulations (such as FDA 21 CFR part 11). Agatha’s clients are typically up and running in a few hours, greatly decrease their compliance risk, and reduce the time spent to manage their clinical, quality and regulatory documentation by 80% in average. Agatha is therefore the trusted partner of more than 100 hospitals, research centers, CROs, pharmaceutical companies and medical device companies worldwide. https://en.agathalife.com
Contact
Company: Agatha Inc.
Contact: Guillaume Gerard
Tel: +33 9 74 59 52 99
Email: info@agathalife.com
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