Matthias Stiene Email & Phone Number

Core expertise is the registration of medical devices in the European Union and the United States to allow the legal placement of such products on the market and communication with the applicable authorities, notified bodies, or ethic committees / clinical review boards. Furthermore, I supported the compilation of registration dossiers for Australia, Brazil, Canada, China, and Russia. Technical documentation and dossiers are typically provided in a STED format adapted to the local requirements of target countries, or with the applicable 510k format for US filings.These RA activities are supported by a firm knowledge of quality management and its necessary skills to perform risk and gap analyses, complaint management, documents control, post market surveillance activities as well as external (vendor) audits. These activities are aligned with the compulsory standards including but not limited to the EN ISO 13485, EN ISO 14971 and published MDCG guidances for EU 2017/745 (MDR), see executive summary above.

Regulatory Affairs Expert with 20 years + experience • EU CE marking according to regulation EU 2017/745 (MDR) and conversion of legacy products from 93/42/EEC (MDD) to MDR • the same services are provided for In-vitro-Diagnostica according to regulation EU 2017/746 (IVDR) and EU directive 98/79/EC (IVDD) • Technical documentation for submissions to Notified Bodies according to EU 2017/745 (MDR) and EU 2017/746 (IVDR) • Labelling and electronic instructions for use according to EU 2017/745 (MDR) and regulation EU 2021/2226 • Quality Management and Audit support • Post Market Surveillance and periodic safety update reports (PSUR) ◦ Complaint Management and Corrective and Preventive Action (CAPA) • Medical device experience with: ◦ Active and passive medical devices ◦ Software medical devices (software as a medical device) ◦ Medical devices containing software (PEMS) ◦ Medical device systems • In-vitro-Diagnostica experience with: ◦ Layman devices and near patient testing ◦ Electrochemical and photometric sensors and biosensors ◦ Immunoassays and antibody/antigen detection systems • Expert with regulatory standards and procedures for conformity assessments and gap analysis according to: ◦ Qualtiy management – EN ISO 13485 ◦ Risk management – EN ISO 14971 ◦ Usability validation - IEC 62366-1, IEC 60601-1-6, Human factors ◦ Medical device software - IEC 62304 and Health-Software IEC 82304 ◦ Basic safety and essential performance, EMC - IEC 60601-1, IEC 60601-1-2 ◦ Applicable MedDev and MDCG Guidances • International applications ◦ USA – 510(k) Submissions ◦ Documentation and support for registrations in Australia, Brazil, Canada, China, and Russia

Key areas: Development of optical enzyme sensors (test strips) based on a high speed printing technology. Patent portfolio management.

Key areas: Continuous glucose monitoring, microfluidics, electrochemical enzyme sensors.

Key areas: Integrated blood glucose sensors, continuous glucose monitoring, electrochemical enzyme sensors.

Key areas: Electrochemical enzyme sensors, enzyme inks and printable electrode materials.

Key areas: ELISA and electrochemical immunoassays for the detection of virus proteins.