Howard Shapland

WORK HISTORY

SKILLS

ABOUT HOWARD SHAPLAND

Howard is the CEO and a founding shareholder of UroPharma, an international medical device company operating in the US and UK. He is also a founder and principal of BioVenture Development, a regulatory consulting company established in 2009 which specialises in advising on regulatory matters in the medical device sector. He is a certified Lead Auditor for ISO 13485:2016, the international standard for quality management, and has over 30 years of experience in medical device design and associated regulatory matters. He is recognised as a Responsible Person for Regulatory Compliance under the European Medical Device Regulations (MDR 2017/745). With vast experience in the field of In Vitro Diagnostics and medical device development, Howard has held many senior positions with multinational pharmaceutical companies, including 15 years with Abbott Laboratories – in which he was based in Australia, Europe, and the Middle East.As Group Compliance Director with International Medical Devices PLC, Howard introduced ISO 9001 and ISO 13485 quality management systems to the group, CE Marked medical devices and maintained regulatory compliance. Howard has also developed and secured multiple patents for medical devices and related components.