Robert Rogers Daniel Young 11 November 2021

Hello, I'm Bob...

"Knowing the potential of each medical device to improve patient outcomes has been and continues to be imminently satisfying, especially as we apply quality assurance best practices and continue to decipher and adhere to new regulatory schema around the world."
Bob is an expert regulatory advisor in the US and EU, as well as Canada and Australia.

Bob has a proven history of product submission and negotiation skills with FDA, Health Canada, TGA and EU Notified Bodies, with successful 510(k) submissions (Traditional and Special), Custom Device Exemption, MAF, Class 2 and Class 3 (ultrasound) medical device applications to Health Canada as well as multiple EU CE Technical File and TGA submissions.

Bob is highly experienced in quality system creation, and remediation leadership to comply with US 21 CFR Parts 803, 806, 812, 820, 830, 210 and 211; ISO 13485:2003, MDSAP, MDR/IVDR, and multiple international compliance requirements.

He has been responsible for building full regulatory teams, including the QA/RA Manager and Management Representative. Also, formed and led a worldwide multi-disciplinary team to ensure compliance with Unique Device Identification requirements.

As a post-market activity expert, he successfully led a busy complaint handling department with greater than 2000 complaints per month and greater than 500 adverse event reports per month in the United States, Canada and in close coordination with EU and Australian cohorts. Also authored and submitted multiple recall notifications in US and Canada and led worldwide recall response teams, leading to successful recall closures.

He is experienced in domestic and international audit performance and management.

In his work, his engagements include Invacare, QIAGEN, Checkpoint Surgical, American IV Products, EyeTel Imaging, and Guilford Pharmaceuticals.

Contact Digital Health Works
Contact Bob Rogers

Bob has over 20 years experience in the field of medical device regulations.

Looking for advice from a veteran expert in quality management and regulatory affairs? He’s here to help.

Let's start a conversation...