Dr. Gabriele Heitner

Why I do this

Medical device manufacturers are under enormous regulatory pressure. The MDR has tightened requirements, Notified Bodies are reviewing more rigorously, and deadlines are getting shorter. Small and medium-sized companies in particular face the question: how do we manage this with limited resources?

I have specialised in exactly this situation — because I know it from first-hand experience. More than 20 years of working in the medical device industry have shown me that many manufacturers don’t fail because of a lack of willingness to comply, but because of a lack of specialised capacity. The clinical evaluation is the most common bottleneck.

With HeiMed®, I offer exactly that capacity: Focused. Personal. Audit-ready.

My background

Education:

• Diploma in Physics, graduated as Dipl. Phys.
• German-Italian Joint Doctorate in Medical Physics, graduated as Dr. rer. nat. (D) and Dottoressa di Ricerca (I)

Professional experience:

• 12 years in specialist and leadership positions in industry
• Founded HeiMed®: 2006

Areas of expertise:

• Clinical evaluation and CER in accordance with MDR Annex XIV
• PMCF planning and evaluation, including development of study designs
• Building or updating the “PMS system”
• Technical documentation for Class IIa/IIb/III medical devices
• Risk management documentation in accordance with ISO 14971
• Working with Notified Bodies

Specialisations:

• Ophthalmology
• Dermatology
• Orthopaedics
• Gynaecology
• Cardiology

What defines my work

I know the Notified Body perspective.

More than 20 years of experience in the industry have shown me how reviewers think, what questions they ask, and where the most common deficiencies lie. I write documentation that answers these questions — not only when challenged, but from the outset.

I take the time to understand your device.

Clinical evaluations cannot be delivered off the shelf. Every device has its own clinical data landscape, its own risk profile, and its own regulatory context. I take the time to understand your device before I start writing.

I’m honest.

If the clinical evidence of your data or the equivalence argument isn’t viable, I’ll say so. If the data isn’t sufficient to support a conclusion, I’ll say that too. You don’t need a consultant who tells you what you want to hear — you need one who tells you what your Notified Body needs to hear.

I deliver results, not interim reports.

What I hand over to you, you can submit. No drafts that need internal rework. No presentations with recommendations that someone else has to implement. Finished, audit-ready documents.

What a collaboration looks like

I work with manufacturers, not for manufacturers. That means: I bring the regulatory expertise, you bring the product knowledge. Together, we create documentation that combines both.

In practice, this looks like:

• At the start we discuss your situation, the scope, and the priorities. You receive a clear proposal.
• During the work I coordinate regularly with you — on technical questions about the device, on regulatory decisions, on interim results. No weeks of silence.
• At the end you receive finished documents with a clear handover. If your Notified Body has follow-up questions, I support you with those as well.

I work remotely and am used to collaborating with teams across different time zones. Communication is via email, video call, or phone — whichever works best for you.

Personal

Success, for me, means when my work sustainably advances my clients’ projects.