EU, here comes Innovation!
Innovation is happy to announce the compliance with Directive 93/42/EEC which provides us the ability to sell our medical device at the European Union market!
Directive 93/42/EEC of the European Union (EU) (also known as the Medical Devices Directive - MDD) details the Essential Requirements manufacturers and importers must meet to apply the CE mark and legally market or sell their devices in the EU. Because of the many types of devices covered by the MDD, the specific requirements depend on the classification and intended use of the device.
As part of the Notified Body assessment, Innovation developed technical documentation in order to provide a compliance of our device against the essential requirements and establish a quality management system that meets the requirements of the MDD. In this way, we state that our medical device complies with the regulations of legislation and the EU regulations regulating the field of medical devices and guarantee a safe and professional medical device. Conformity with the requirements of the EU regulations for medical devices and the legislation is proved by the granted EC Certificate.
ISO 13485:2016 Certification Achieved!
We are again proud to announce we have achieved ISO 13485:2016 certification for a Quality Management System (“QMS”) for the design and manufacture of Medical Devices.
This certification process reflects a culmination of Innovations's ongoing commitment to quality during the production, manufacturing and distribution of medical device applications.
With this certification, Innovation is committed to providing our customers with a best-in-class customer experience. We are dedicated to developing products of the highest quality while operating under a QMS that drives continuous improvement.
Final Reports - Medical Electrical Equipment and Medical Device Software
Seal of excellence SME1/SME2 phase Oct/Nov 2017 H2020 EU
Happy World Standards Day!
Each year on 14 October, we celebrate #WorldStandardsDay, which is a means of paying tribute to the collaborative efforts of thousands of experts worldwide who develop voluntary technical agreements that are published as International Standards.
We at Innovation are proud to say that we are compliant to the following ISO standards:
• ISO 9001:2015 - Quality management systems — Requirements
• ISO/IEC 27001:2013 - Information technology — Security techniques — Information security management systems — Requirements
• IEC 62304:2006 – Medical Device Software – Software Lifecycle processes
• IEC 60601-2-47:2012 - Medical electrical equipment - Part 2: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
• IEC 60601-6:2010 - General requirements for safety – Collateral Standard: Usability
• ISO 13485:2016 – Medical Devices - Quality management systems — Requirements for regulatory purposes
• IEC/TR 80002-1:2009 - Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
• EN ISO 14971:2019 - Medical devices - Application of Risk Management to Medical Devices
Standards make our work easier and our @ECGAlert & @Glyco software better!
Potential of Wearable Sensing and Telehealth Technologies in the Coronavirus Pandemic
We live in strange and unsafe times. The COVID-19 pandemic brought big changes to our lives. It has encouraged us to put our health as the focal point of our daily routines and highlighted the importance of keeping regular track of our health.
At ECGalert, we are dedicated to addressing the problem and finding (at least) part of the solution. That is why, we would like to underscore the importance of telehealth technology as well as wearable sensors in the fight against the COVID-19 pandemic.
Paired with the sensor Savvy, ECGalert software is capable of detecting problems and complications as a result of the coronavirus in both patients and frontline medical workers. Because of the wireless connection from the software to the sensor, doctors can work on their patients’ health uninterruptedly, while patients focus on their recovery as they are monitored 24/7.
Even more importantly, ECGalert is capable of automatic detection of a-fib in COVID-19 patients, which usually results from some particular types of treatment, like those with hydroxychloroquine and azithromycin. Automatic and early detection is of paramount importance in these cases so the doctors can administer timely treatments.
Finally, on top of these excellent features that our sensor and software offer, our customers have access to a dedicated medical team which can help them 24/7.
Interested to learn more about ECGalert? Contact us at hello@ecgalert.com
Another certification announcement, this time it’s ISO 27001:2013
We are once again proud to announce that Innovation has achieved ISO 27001:2013 certification of our Information Security Management System (ISMS) covering our infrastructure, data centers, and services.
ISO 27001:2013 is a widely-adopted global security standard that sets out requirements and best practices for a systematic approach to managing company and customer information. In order to achieve the certification, a company must show it has a systematic and ongoing approach to managing information security risks that affect the confidentiality, integrity, and availability of company and customer information. That’s why, Innovation’s security compliance was validated by an independent audit firm after a rigorous process of demonstrating an ongoing and systematic approach to managing and protecting company and customer data.
Protecting customer and researcher data is of the utmost importance to us and this ISO 27001:2013 is just the start. We have a lot planned for our security compliance roadmap so stay tuned!
