Services for small MedTech manufacturers

📚

Language / Sprache / Sprog

English (current) · Deutsch – Leistungen für kleine Medizintechnik-Unternehmen · Dansk – Services til små MedTech-virksomheder

🎯 At a glance

👥 Typical organisations I work with

Small MedTech manufacturers and healthcare technology companies (roughly 10–50 people)

Teams that already have internal or external RA/QA roles in place

Organisations with products in development or on the market, often with IEC 62304‑ or ISO 13485‑relevant software or devices

Setups where structures exist in principle, but documentation, processes, and responsibilities have grown unevenly over time

How different roles might use this support

RA / QMS directors: When structural work on documentation, processes, and interfaces is needed, but internal RA/QA capacity is mostly consumed by assessments and decisions.

Founders / CTOs in early MedTech teams: When "grown" documentation and unclear responsibilities start to slow down development, onboarding, or external conversations.

Operational leads (e.g., service, support, product): When everyday workflows touch regulatory or quality topics, but there is no clear, shared picture of who does what, when, and with which information.

For whom: Small MedTech manufacturers and healthcare technology organisations in Germany and the Nordics who already work with qualified RA/QA roles.

What I offer: Structural support for documentation, processes, and responsibilities where technical work, regulation, and everyday practice meet.

What I do not replace: Regulatory Affairs responsibility, PRRC roles, or ownership of your quality management system.

I work with small MedTech manufacturers and healthcare technology organisations in Germany and the Nordics, focusing on documentation, processes, and responsibilities where technical work, regulation, and everyday practice meet. This page outlines the type of structural support I offer within my connector role, without replacing Regulatory Affairs or Quality Management functions.

Why this type of support

My background in pharmacy, industrial quality environments, and process-oriented work has been shaped by questions of safety, traceability, and clarity in documentation. Over time, this has led to a connector role at the intersection of MedTech, regulation, and practice along the DE–DK–SE axis, with a focus on structures that help small organisations keep their work understandable and auditable.

📄 Structuring technical documentation

Many small manufacturers have documentation that "just grew over time": different formats, different voices, and a mix of legacy and new content. This section describes how I help turn that into clearer, more consistent structures that people can work with reliably.

I support you in turning existing documents into clearer, more consistent structures that are easier to maintain and to hand over between roles.

Examples

Making internal technical descriptions and reports easier to follow for both engineering and QA/RA

Creating or refining document structures that fit your current quality system maturity

Cleaning up and re‑structuring existing documents without changing your technical content

Typical outcomes

Clear outlines for key document types (for example development documentation, internal descriptions, work instructions in a technical context)

Revised documents with improved structure, readability, and traceability

Suggestions for terminology and layouts that support future growth

💡

The aim is to make documentation easier to work with in day‑to‑day practice and more transparent for quality and regulatory stakeholders.

🔍 Targeted research and regulatory landscape overviews

Small organisations often do not have capacity for deep research on every new topic. This section explains how I support concise, referenced overviews so that your experts can decide what is relevant for your situation.

I create structured summaries of technical, organisational, or regulatory topics that your internal RA/QA and technical roles can build on.

Examples

High‑level overviews of relevant standards and guidance documents for a specific topic

Brief summaries of technical or organisational approaches used in similar contexts

Collections of sources that your internal RA/QA people can build on

Typical outcomes

Short, structured overview documents with key messages and links to original sources

Tables or one‑page profiles of standards, guidance documents, or technical concepts

Practical suggestions for where this information might affect your current processes or documentation

💡

The goal is to give your experts a well‑organised starting point so that their time can focus on assessment and decision‑making rather than basic information gathering.

🔁 Visualising processes, interfaces, and responsibilities

In small organisations, people often work across several areas at once. That makes it important to be clear about who does what, when, and with which information. This section describes how I help make those flows visible without over‑engineering them.

I support you in mapping key processes so that responsibilities, handovers, and information flows become more transparent for everyone involved.

Examples

Simple process maps from idea to released document or from development to market support

Clarifying who decides, who contributes, and who needs to be informed in key steps

Making existing informal practices visible and discussable

Typical outcomes

Process diagrams that both operational teams and management can understand

Clear descriptions of responsibilities and handovers

A better shared understanding of how work actually flows today – and where small, realistic changes could help

💡

Process visualisations are intended as working tools for your team. They should support real decisions, handovers, and audits, not exist only as diagrams.

🧩 Structuring requirements and cross‑functional interfaces

Requirements often come from many directions: clinical needs, customers, standards, IT, cybersecurity, production, and more. This section explains how I help you bring structure into that complexity.

I support you in ordering and phrasing requirements so that responsibilities and dependencies become clearer across functions.

Examples

Grouping requirements by topic and owner (for example engineering, QA, RA, IT)

Creating overviews of "Who needs which information at which point in time?"

Supporting your internal teams in connecting technical requirements with quality and regulatory expectations

Typical outcomes

Structured requirement lists with categories and clear ownership

Suggestions for how requirements can be embedded into your current documentation and quality structures

Better alignment between development, IT, quality, and regulatory work

💡

The intention is to make requirements manageable and traceable in day‑to‑day work, especially where technical, clinical, and regulatory expectations overlap.

💼 How collaboration works

The way we work together is designed to be transparent, low on overhead, and compatible with your existing structures and roles.

1. Initial conversation (online, ~30–45 minutes)

We clarify where you are today, what you want to achieve, and which constraints you are working under. We also check whether my profile and your needs are a good match.

2. Short written scope

You receive a brief, written scope describing:

what I will work on,

what remains clearly in your responsibility (for example final RA/QMS decisions),

and which outcomes we aim for in this first step.

3. Work in small, defined packages

To keep things manageable, we work in small packages – for example:

a structure proposal for one key document,

a clean‑up pass on existing content,

or a process map including responsibilities.

4. Handover and next steps

You receive the results in formats that fit your existing tools and systems. If it is useful, we define a next small step rather than a large, open‑ended project.

💡

The focus is on practical steps that improve structure and clarity, while strategic and regulatory decisions remain with your internal or external experts.

⚠️ Clear scope and boundaries (roles and responsibility)

The following boundaries are important to keep collaboration fair, safe, and transparent for both sides.

⚠️

Professional and regulatory boundaries

I do not act as your person responsible for regulatory compliance (for example PRRC under the MDR), and I do not make final regulatory approval decisions.

I do not create standalone, final ISO 14971 risk assessments under my own responsibility. I can contribute to structure, traceability, and documentation within your existing RA/QMS framework.

I do not design, implement, and own a complete quality management system for you, and I do not perform audits under my own name.

My role is to help you:

make documentation and structures more usable,

improve clarity in processes and responsibilities,

and support your internal and external experts with better information.

The professional and legal responsibility remains with your organisation and its qualified roles.

🎯 Is this for you?

This section is intended to help you quickly assess whether this type of collaboration fits your situation.

A good fit if

You are a small MedTech manufacturer or healthcare technology company in Germany or the Nordics

You already have, or work with, qualified RA/QA roles (internal or external), but need more structure and capacity in documentation and processes

You value transparency about what a collaboration can and cannot cover

Not a good fit if

You are looking for someone to fully take over RA responsibility or a PRRC role

You want a complete QMS to be designed, implemented, and maintained externally

You expect legally binding regulatory decisions without appropriate internal or external expert responsibility

📬 Next steps

If this direction of support is relevant to your situation, you can reach out with:

one sentence about your organisation and product(s),

one sentence about your current challenge,

and, if possible, a brief example (for instance a document or short description of the main pain point).

I will respond with a proposal for an initial conversation and a clearly defined next step.

Back to Start / Short Profile