Your partner for clear market access – regulatory services for medical devices and IVDs
From complexity to clarity
in regulatory affairs
One partner for all regulatory requirements — from approval to market surveillance.
Structured. Hands-on.
What we do for you
Comprehensive support throughout the entire regulatory approval process – from strategy through Technical Documentation, QM, and Clinical Evaluation to CE Marking. Coordinated across disciplines, efficiently implemented, and with a focus on what is feasible.
Whether you need targeted support or ongoing guidance – backed by over 20 years of regulatory expertise.
400+
certifications for QMS
380+
international approvals
250+
seminars per year
“For the first time, we felt that someone had a grasp of the entire regulatory process — not just their part of it.”
Head of QA, Class IIb manufacturer
Our customers
Medical Device
manufacturers
Start-ups
Suppliers for medical devices / IVD
Authorities
IVD manufacturers
Investors
Our services
From the initial regulatory assessment to ongoing market support – a comprehensive one-stop shop.
Products we work with
Medical Devices Class
I, IIa, IIb, III
IVDs
A, B, C, D
Active and non-active Medical Devices
Combination Products
Medical Device Software
Our long-standing partners
The solution
When regulatory affairs become a burden
Requirements grow faster than we can keep track.
Documents pile up. Decisions are left pending. The next audit approaches – and with it, uncertainty.
This is exactly where we come in
We provide orientation, reduce complexity, and empower your team – with clear processes, proven tools, and a focus on what matters most.
Not everything at once. Not more than necessary. But exactly what your situation requires right now.
The difference:
our QMS Update Service
Don’t want to manually adjust your QMS every time there is a regulatory change?
Our QMS Update Service identifies changes early, classifies them, and implements them directly when needed – traceably, efficiently, and without additional effort for your team.
Let’s talk about it.
Learn more about our QMS Update Serviceour approach
What will change for you
in the long term
You don’t just get consulting – you get structures that last, clarity that works, and a team that acts with confidence. Not just in the project – but in daily operations, in audits, and throughout the entire Product Lifecycle.
Clarity instead of complexity
Stable processes. Reliable audits
Compliance that lasts
The people behind the clarity
You work with people, not consultants
Regulatory affairs affect people. Decisions. Responsibility.
That is why we listen, understand your situation, and guide you so that clarity emerges – step by step.
“Our goal is to equip teams so they can act with confidence.”
Founder, regular services
“There’s no one-size-fits-all solution for every customer. We listen first, then we develop the solution – not the other way round.”
Senior Consultant, regular services
Results
from real-world practice
Our clients are best placed to demonstrate what regulatory clarity means in practice.
News
Practical knowledge, regulatory updates, and events – directly from our LinkedIn feed.
regular services rs GmbH
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regular services rs GmbH
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