Experienced regulatory and quality perspective for medical device and IVD leaders.
Jon Ward provides strategic regulatory and quality advisory for medical device and IVD leaders who are responsible for complex, high-stakes decisions.
His value is not only technical expertise. It is perspective, pattern recognition, strategic judgment, and the ability to help leaders see the path forward when regulatory or quality decisions become unclear.
Medical device and IVD leaders bring Jon in when they need:
Regulatory strategy perspective
Quality system judgment
Submission pathway guidance
Audit preparation insight
Market-entry clarity
Risk-based decision support
A second set of experienced eyes
Help moving from uncertainty to confidence
Bring experienced regulatory and quality perspective into the room.
Why Leaders Bring Jon Into the Conversation
25
YEARS
700+
MANUFACTURERS
150+
FDA 510(k)s
100+
CE documentation reviews.
About Jon Ward
Strategic regulatory and quality advisory for medical device and IVD leaders
My name is Jon Ward. I work with regulatory and quality leaders in the medical device and IVD industry who carry significant responsibility under constant pressure.
This work exists for the moments when the path forward is complex, the requirements are unclear, or an important decision needs to be made quickly. My role is to provide a trusted point of reference so leaders and their teams can think clearly, weigh the risk, and move forward with confidence.
My approach is grounded in 25 years of global experience supporting more than 700 manufacturers and product teams. Over that time, I have prepared and overseen more than 150 successful FDA 510(k) submissions, more than 100 CE technical documentation reviews under the MDD and MDR, and dozens of Canadian and Australian market applications.
I have conducted hundreds of internal and supplier audits under FDA QSR, ISO 13485, MDSAP, MDR, and IVDR. I have also sat across the table from regulators, notified bodies, and auditors around the world, giving me practical insight into how regulatory and quality decisions are evaluated in real time.
In addition to regulatory and quality advisory work, I have founded and led offices in the U.S., UK, EU, Switzerland, Australia, and New Zealand to support clients locally as Authorized Representative, UK Responsible Person, and Sponsor. Alongside consulting, I have trained and mentored RA/QA professionals through AAMI and university partnerships, helping build the next generation of regulatory and quality leaders.
My academic background includes a BS in Psychology, an MBA, and a DBA with a focus on International Business. My doctoral dissertation examined best practices in regulatory strategy, combining academic research with decades of applied experience. That blend of education and real-world perspective shapes the way I help leaders make sound decisions, strengthen their teams, and build lasting capability.
Outside of work, I am an avid hybrid athlete and can frequently be found at Spartan obstacle course races, testing both mental and physical fortitude. I am no stranger to difficult terrain. That same mindset carries into my advisory work: stay steady under pressure, read the landscape clearly, and find the next right move.
The value is straightforward: practical, real-world guidance that helps medical device and IVD leaders make confident decisions when the next decision matters.
Jon’s Approach
Jon’s advisory work is built around guiding principles
Together, this gives medical device and IVD leaders the kind of strategic regulatory and quality advisory they need most: clear perspective, grounded judgment, and confidence when the next decision matters.