Heiko Richard, a passionate Medical Technology Expert with over 16 years of experience in MDR and IVD/R regulations. His goal is to help companies succeed in their industry by sharing his knowledge and skills. With a clear focus on design quality and navigating the complex regulatory environment, Heiko brings innovative approaches and a solution-oriented mindset.
Heiko’s expertise includes:
• Design Quality and Regulatory Compliance: Ensuring product and documentation conformity throughout the entire product lifecycle and proactive application of the quality management system according to ISO 13485 and 21 CFR Part 820.
• Risk Management and Product Safety: Actively contributing to the reduction of product risks and ensuring product safety through risk analyses according to ISO 14971.
• Quality Assurance Processes: Proven expertise in quality assurance processes during development up to manufacturing.
• Communication and Teamwork: Ensuring a smooth flow of information through effective communication with development and production teams.
• Regulatory Requirements: Comprehensive support for documentation through development and updates for medical software according to IEC 62304 and ensuring compliance with the guidelines for MDR ((EU) 2017/745) and IVDR products (2017/746).