David Didsbury Email & Phone Number | I am a Quality and Regulatory Affairs Consultant with a solid academic background, and comprehensive skill set coupled with a breadth of experience over a wide range of industries and business areas. I believe I can bring a powerful blend of hands-on quality management combined with the latest thinking in regulatory affairs and international standards. I am a committed team player with leadership abilities who uses soft management skills to establish collaborative working style coupled with a proactive and energetic can-do attitude. My key achievements include: Quality Management System • Implemented & developed the QMS in line with company growth plans. (350K to 4 million) • Helped SME convert from ISO 13485:2012 to ISO13485:2016 • 100% Success rates with FDA audits • Product Registration in Europe (CE), America (FDA) Canada, Far East including Japan • Helped SME successfully introduce FDA/ ISO 13485 compliant Design & Development processes (IEC60601 and IEC62304, firmware, PC, cloud and mobile apps) • Year on year reduction in customer complaints & warranty costs • Introduction of a customer focused complaint handling methodology that improved the end-users perception of the organisation • Promotion of risk awareness and strategies to reduce both technical and commercial risk • Senior management role in supporting the growth of the BPR business • Introduction of automotive best practice - PPAP, for plastic mouldings, hands on experience gained in China. • Project managed the move of a key manufacturing line to China, on time and within budget • China - Organised and ran a successful supplier evaluation for a high precision plastic tool maker & moulder. I understand the true meaning of the Chinese, "I can do culture" • Proven experience of project leadership in NPD & NPI • Installation of three environmentally controlled rooms (including a 10K cleanroom) to improve the quality of products at BPR

David Didsbury

I am a Quality and Regulatory Affairs Consultant with a solid academic background, and comprehensive...
Bingham, England, United Kingdom

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David Didsbury’s Email david.didsbury@bprmedical.com

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David Didsbury’s Location Bingham, England, United Kingdom

David Didsbury’s Current Industry Didsbury Meddev

David Didsbury’s Prior Industry Bpr Medical | Pitney Bowes | Gammex Rmi

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Work Experience

Didsbury Meddev

A freelance Quality and Regulatory Affairs Consultant

2017-06-01 00:00:00 - Present

Bpr Medical

Quality and Regulatory Affairs Manager

2006-11-01 00:00:00 - 2015-04-01 00:00:00

Pitney Bowes

Software Development Manager

2003-01-01 00:00:00 - 2006-10-01 00:00:00

Gammex Rmi

Technical manager

1992-01-01 00:00:00 - 1998-01-01 00:00:00

Skills

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FAQ About David Didsbury

David Didsbury is located at
Bingham, England, United Kingdom

David Didsbury is a I am a Quality and Regulatory Affairs Consultant with a solid academic background, and comprehensive skill set coupled with a breadth of experience over a wide range of industries and business areas. I believe I can bring a powerful blend of hands-on quality management combined with the latest thinking in regulatory affairs and international standards. I am a committed team player with leadership abilities who uses soft management skills to establish collaborative working style coupled with a proactive and energetic can-do attitude. My key achievements include: Quality Management System • Implemented & developed the QMS in line with company growth plans. (350K to 4 million) • Helped SME convert from ISO 13485:2012 to ISO13485:2016 • 100% Success rates with FDA audits • Product Registration in Europe (CE), America (FDA) Canada, Far East including Japan • Helped SME successfully introduce FDA/ ISO 13485 compliant Design & Development processes (IEC60601 and IEC62304, firmware, PC, cloud and mobile apps) • Year on year reduction in customer complaints & warranty costs • Introduction of a customer focused complaint handling methodology that improved the end-users perception of the organisation • Promotion of risk awareness and strategies to reduce both technical and commercial risk • Senior management role in supporting the growth of the BPR business • Introduction of automotive best practice - PPAP, for plastic mouldings, hands on experience gained in China. • Project managed the move of a key manufacturing line to China, on time and within budget • China - Organised and ran a successful supplier evaluation for a high precision plastic tool maker & moulder. I understand the true meaning of the Chinese, "I can do culture" • Proven experience of project leadership in NPD & NPI • Installation of three environmentally controlled rooms (including a 10K cleanroom) to improve the quality of products at BPR