Leeanne has extensive experience of Regulatory & Quality projects from companies who have dealt with a range of products including Neurology, Diagnostics, Orthopaedics and Contraceptive Devices.
She has also performed Clinical Literature Evaluations for CE marking and 510(k) projects, as well as submissions for worldwide markets including Australasia and Canada.
He has also performed Clinical Literature Evaluations for CE marking and 510(k) projects, as well as submissions for worldwide markets including Australasia and Canada.
James has extensive experience of Regulatory & Quality projects from companies who have dealt with a diverse range of products and services.
He has also performed Clinical Literature Evaluations for CE marking and 510(k) projects, as well as submissions for worldwide markets including Australasia and Canada.
Michael has over 20 years experience in the Medical Device industry, in the USA and Ireland, overseeing projects as diverse as building a manufacturing plant to managing international product distribution channels.
As well as acting as the US representative for companies planning to enter the US market, he also offers a range of Quality and Auditing services to help organisations withstand scrutiny from the FDA and other Government agencies.
Product Development & Project Management
He has consistently delivered new product development/improvement projects and critical recovery projects - all within scope, on-time and on-budget.
Whether it's evolving a product, performing a validation, auditing a supplier or training staff, Steve prides himself on delivering a solution quickly and effectively. He can help from initial concept through to full project management and product delivery.
David is a talented graphic artist who works with ABC to develop, simplify and illustrate instructions for use (IFU) documents to improve product usability.
He started as an orthopaedic product engineer, progressing to Senior VP at Symmetry Medical Europe. He now works as a consultant and also chairs the Sheffield City Region LEP Health Technologies Sector Group.
He also has experience with regard to post-market interactions with Notified Bodies and Competent Authorities, as well as dealing with pre-submission, IDE and 510(k) submissions for the US FDA.
Ted has over 25 years experience in the pharmaceutical industry, consulting in all aspects of strategic business development across Asia - especially in Japan.
His broad knowledge and skills can help with the complexities of regulatory and cultural issues for anyone planning on entering the Asian market.
eQMS software to help you get to market faster
Our aim at Acclaim Biomedical Consulting (ABC) is to provide you with an independent, pragmatic approach to meeting these requirements so that you can manage your business successfully. By using our network of expert consultants, associates and partner companies we can bring together decades of relevant experience – from quality assurance and clinical research to product design and market development.
Acclaim Biomedical Consulting Ltd
