Johan Comstedt

Johan Comstedt has a diverse work experience in regulatory engineering and affairs. Johan is currently working at Plejd as a Regulatory Engineer since November 2022. Before that, they were a Senior Regulatory Affairs Engineer at Breas Medical from January 2018 to November 2022. Prior to Breas Medical, Johan worked at Ascom Sweden AB from February 2011 to January 2018 as a Quality Assurance & Regulatory Affairs Manager and later as a Regulatory Specialist. Johan started their career as a Consultant at i3tex AB, where they worked on the development of test equipment for a medical device lung ventilator and later became a regulatory specialist for Ascom (Sweden) AB.

Johan Comstedt attended Halmstad University from 2005 to 2008, where they pursued a degree in Elektroteknik (Electrical Engineering).

In terms of additional certifications, Johan obtained the following certifications:

- In November 2018, they acquired certification in IEC 60601-1 3rd ed. incl. Amd 1 and risk management from Intertek Sweden.

- In April 2016, they obtained certification in EN ISO 13485 2012/2016 version from Symbioteq Kvalitet AB.

- In June 2015, they acquired certification in IEC/EN 62368-1 from Intertek Semko AB/Intertek Academy.

- In April 2014, they obtained certification in EN60601-series, Medical Electrical Equipment and system from Symbioteq Kvalitet AB.

- In October 2013, they obtained certification in Design Control Requirements and Industry Practice from AAMI.

- In May 2012, they acquired certification in ATEX - regler för explosiv gas- och dammatmosfär from Teknologisk Institut AB.

- In March 2012, they obtained certification in MDD, 510(k) och QSR för Medicintekniska produter from Key2Compliance®.

- In February 2012, they acquired certification in Globalt marknadstillträde för medicintekniska produkter from SIS, Swedish Standards Institute.

- In February 2012, they obtained certification in RoHS 2 from Intertek Semko AB / Intertek Academy.

- In February 2012, they acquired certification in Usability enligt EN 62366 from SIS, Swedish Standards Institute.

- In February 2012, they obtained certification in Utveckling av medicinteknisk mjukvara enligt EN 62304 from SIS, Swedish Standards Institute.

- In October 2011, they acquired certification in Kvalitetssystem för medicintekniska produkter from SIS, Swedish Standards Institute.

- In October 2011, they obtained certification in Oracle Agile 9.3.1 Product Governance & Compliance Ed1 PRV from Oracle University.

- In September 2011, they acquired certification in Grundutbildning i ATEX-direktivet 94/9/EG from Nemko.

- In September 2011, they obtained certification in Regelverket för medicintekniska produkter, grundkurs from SIS, Swedish Standards Institute.

- In March 2010, they acquired certification in Europeiska EMC-krav from EMC Services.