Klaus Hammer

Senior executive with current MedTech quality and regulatory affairs leadership experience, including SaMD QMS build-up, ISO 13485:2016 certification readiness, EU MDR CE certification work and international medical device registrations. Combines quality and regulatory depth with CEO-level P&L ownership, global leadership, McKinsey consulting experience and organizational transformation expertise.

Head Regulatory & Quality Assurance at Perivision SA (2022-11 – Present)

Member of the Perivision Senior Management Team. Manage regulatory and compliance aspects of a MedTech start-up.

• Achieved certifications for medical devices in USA, EU MDR, UK and Rest of World markets.
• Built a QMS for software as a medical device (SaMD) from scratch within six months; currently in advanced ISO 13485:2016 certification process with notified body.
• Support MDR 2017 SaMD CE certification process with notified body.
• Execute ongoing regulatory and quality tasks across the organization.
• Train all Perivision staff in medical-device compliant processes.
• Advise management on cybersecurity, data protection and legal matters.

Managing Director (20%), Owner at HammerResults GmbH and KHammer Consulting (2017-01 – Present)

• Lead culture and organizational health surveys.
• Deliver organizational improvement projects in the USA and EMEA.

Commercial Lead at Genioo Workforce Solutions (2014-08 – 2016-12)

• Conceptualized and implemented survey methodology.
• Led business development and built client network in private equity, pharmaceutical, MedTech and professional services markets.

General Manager EMEA, OHI Solution at McKinsey & Company (2013-09 – 2014-08)

• Member of global Solution Leadership and McKinsey organizational practice.
• Led organizational health projects for clients across EMEA.
• Delivered more than 100 diagnostics and improvement projects.
• Led a team of 14 organizational coaches and experts.

CEO, Owner at Andzyme Global (2012-01 – 2013-08)

• Provided advisory and M&A services for biotech, pharmaceutical and MedTech markets, including in- and out-licensing.
• Contacted and negotiated with heads of business and product development at leading pharma, biotech and MedTech companies.

General Manager, Fund Advisor, Art Buyer at Hammer Gallery / Art Seasons Gallery (2007-01 – 2011-12)

• Founded and managed art galleries with a team of five.
• Participated in art fairs in Basel and Cologne.

Chief Executive Officer (CEO) at Signity AG / Gem.net.AG (1999-01 – 2006-12)

• Held full P&L responsibility for Signity Group with 20 international subsidiaries and branches and more than CHF 150 million in sales.
• Sustained sales and profit leadership in a globally hyper-competitive market.
• Led approximately 300 employees globally.
• Started B2C internet activity Gem.net Inc. in New York.

Executive Vice President, SWAROGEM Division; Member of Group Executive Board at Swarovski Corporation (1993-03 – 1998-12)

• Led a division of 600 employees, including production and 15 international distribution offices.
• Achieved world leadership in key product groups within three years.
• Increased sales by 60%.

Senior Associate at McKinsey & Company (1990-08 – 1993-02)

• Participated in and led client projects in machine tooling, logistics, manufacturing and tourism.

CAS Compliance in Compliance – University of Zurich (2022 – 2022)

Board Membership Course in Board Membership – University of St. Gallen (1992 – 1992)

MBA in Master of Business Administration – University of California at Berkeley (1988 – 1990)

Graduate Degree in Law in Law – Ludwig-Maximilians-Universität München (1983 – 1988)