The problem.
Have you ever faced a strategic decision in regulatory or quality and wanted an independent perspective before committing? These moments often come up in submissions, audit responses, or when shaping a quality system for global requirements.
It may be drafting a response to FDA or EU feedback, preparing for an MDSAP or ISO 13485 audit, or weighing market-entry trade-offs across multiple regions at once. Sometimes it’s updating PMS or PMCF plans and needing confidence that the approach will stand up to review by regulators or notified bodies.
In these situations, having a trusted advisor means you don’t have to carry the pressure alone. The goal is simple: provide clarity so you can make decisions with confidence and keep projects moving forward — wherever you operate.
Trailblazing new ground.
Some challenges don’t come with a map to fit the situation. Leaders are often asked to move first — expanding into unfamiliar markets, building systems for new product types, or adapting to regulations that are still evolving. These situations demand judgment, perspective, and the ability to make sound decisions when precedent doesn’t exist.
With experience across hundreds of companies and regions, the focus is on helping you and your team move forward with confidence — even when you’re the first to take the step. Trailblazing means moving without a template.
Success comes from testing ground, reading the landscape, and making decisions that open the way for others to follow.
Advisor and Coach
Like a navigator guiding a captain and crew, I work with regulatory and quality systems leaders chart their course, anticipate challenges, and reach their goals with confidence. Backed by more than 20 years of global experience with over 700 medical device and IVD innovators, my work spans regulatory strategy, submissions, market access, QMS, clinical affairs, and post market surveillance. The result is practical guidance that helps leaders and their teams make confident decisions and develop talent throughout the journey.
You can learn more about my experience and credentials here.
How We Can Partner Together
For leaders working with a small team (1–3 people) who want to map the route forward together. Charting offers more time and the ability to bring team members into conversations so they develop capability while executing.
Whats Included:
2 × 60-minute or 4 × 30-minute calls each month (120 minutes total)
Priority response to questions
Flexibility to involve your team, so they learn and grow alongside you
Use Cases:
A Director is told to accelerate a 510(k) update while still keeping their MDR project on track. Their small team is stretched and needs to talk through what gets pushed, what can overlap, and how to communicate the trade-offs upstream.
A Manager is heading into a supplier audit when a critical finding from another vendor lands on their desk. They need to figure out whether to adjust the audit scope last-minute and how to brief their two junior staff who are coming along.
A VP wants to standardize PMS reporting, but one product group insists their approach is “different.” The leader brings two team members into a call to hash through the regulatory expectations and align the team on what can be flexible versus what can’t.
The executive team wants a slide deck showing “regulatory readiness” for three launches in different regions. The leader needs to map what’s really ready, what’s still risky, and how to frame it so the board understands the reality without panicking.
Service Fee: $650.00 per month
For individual RA/QA leaders who want direct access to an experienced advisor. Orientation provides steady direction, decision support, and a reliable sounding board.
Whats Included:
2 × 30-minute calls each month (60 minutes total)
Quick follow-up access for clarifications by email, text, or WhatsApp
Ideal for leaders who need clarity and confidence on key regulatory or quality questions
Use Cases:
While drafting a response to FDA or EU authority feedback, a leader wants confirmation that the reply fully addresses the questions before submission.
In preparing for an MDSAP or supplier audit, a manager wants to review their readiness plan and confirm that key risk areas are addressed.
When deciding whether to pursue UKCA marking immediately or delay, an executive needs to talk through regulatory implications and timing trade-offs.
While updating a PMS Plan under EU MDR, a leader wants to validate the scope of activities and check that the approach will stand up to notified body review.
Service fee: $375/month
For organizations managing multiple products, projects, or broader RA/QA teams. Navigation provides the highest level of access, with regular touch points that keep leaders and their teams moving forward across several initiatives at once.
What’s Included:
Four to six advisor sessions each month (~180 minutes total)
Priority response for leaders and teams (typically within one business day)
Flexibility to shift focus between projects, submissions, audits, or strategy discussions as priorities evolve
Use Cases:
A company is pushing a 510(k), an MDR Technical Documentation update, and an MDSAP surveillance audit all within the same quarter. The RA/QA leader needs frequent outside perspective to keep resources aligned and prevent critical details from slipping.
A VP is covering three regions (U.S., EU, and Canada) while onboarding new team members. Regular calls provide a sounding board for high-level decisions while also helping junior staff get up to speed without slowing projects down.
Executive leadership decides mid-year to prioritize a U.S. De Novo over a CE Mark expansion. The RA/QA team needs to pivot quickly and weigh the downstream impacts on PMS, labeling, and supplier readiness.
A manufacturer receives multiple nonconformities across different sites. The RA/QA head wants to use recurring discussions to track responses, verify corrective actions, and keep progress visible at the leadership level.
Service Fee: $1200.00 per month
Schedule an intro call
Set up a free 15-minute call to talk through your role and current regulatory or quality responsibilities. This is an introduction to see if ongoing advisor support is a good fit.
You can reach me at jon@jonward.io or WhatsApp +1-813-784-9657
