Thomas Weber Email & Phone Number

Mableton, GA, US

• Loewenstein Medical Americas Corp. (LMA) is a start-up founded in 2018 to facilitate the market entry of the Löwenstein Medical Group into the North American market. LMA acts as the sales and operations organization.
• Held this position parallel to the CQO position at Löwenstein Medical Technology between 07/2018 and 12/2021
• Founded Loewenstein Medical Americas Corp. as a Delaware Corporation and leading it to profitability within one year
• Developed the company’s strategy and vision
• Recruited and developed executive personnel, administrative and sales staff
• Established a customer service department to provide customers with a direct contact for orders, technical, clinical, and telehealth support and all logistical questions in order to offer a satisfying overall experience

• Löwenstein Medical Technology GmbH+Co.KG (formerly WEINMANN Geräte für Medizin) is a medical device manufacturer for sleep therapy and sleep diagnostic devices, home ventilators, ventilation masks, and telehealth- and.
• Organized and managed the Quality and Regulatory Department in six agile branches. The streamlined quality organization improved the overall compliance and increased time to market for new product developmentso Quality.
• Implemented the Medical Device Single Audit Program as an early adopter to create a temporal advantage over competitors
• Established a group wide audit team to perform internal audits at associated companies
• Reviewed final development documentation and released new products to market
• Personally responsible for product market releases

• Reorganized the International Registration Services into an up-to-date Regulatory Affairs department, reducing product time to market by 20%
• Separated the product registrations of the two business units ‘homecare’ and ‘emergency’ of WEINMANN Geräte für Medizin to prepare the company for a corporate split executed in June 2013. The emergency branch operates.
• Updated all existing product registrations worldwide with the new legal company name.

Hamburg, DE

• PROSYSTEM AG is a consulting company for the life science industry.
• Established a regular training program in the USA providing in-house and open trainings on health industry topics
• Performed mock inspections to prepare customers for an FDA inspection and implemented corrective actions to address process deviations
• Implemented quality and regulatory strategies at customer organizations to address current and future requirements
• Prepared about 40 510(k) submissions and one Premarket Approval submission for customers in different medical fields
• Trained and accompanied product risk management activities according to ISO 14971 standard at US-based customers

Hamburg, DE

• Performed customer trainings on standards as IEC 60601 – Device Safety, IEC 62304 – Medical Device Software, ISO 14971 – Product Risk Management, and ISO 13485 – Quality Management System
• Implemented Quality Management Systems at start-ups and accompanied the certification process
• Prepared Technical Documentations for products with close contact to the customers’ associated departments to receive product certifications

• The mission of the Neuromuscular Research Center of Boston University was to increase the understanding of human motor control and improve the quality of life for the neuromuscularly impaired. It pursued these goals by.
• Developed prototype of a wearable, wireless tactile balance system for patients with peripheral neuropathy to reduce the risk of fall. This included the concept, feasibility study, electronics layout and assembly, as.