Erfahrung
trifft Effizienz:
Regulatory Solutions
für KMUs und Startups
Experience meets efficiency
Regulatory Solutions
for SMEs and startups
IN PARTNERSHIP, PROFESSIONAL, RELIABLE:
This is how we get your registration to the finish line as quickly as possible.
With over 40 years of regulatory affairs experience in the fields of medical technology, life sciences and healthcare, we are the perfect partner for the successful approval of your medical devices!
As an expert at your side, we see it as our task to guide your innovation through the regulatory approval process as quickly as possible!
Our offer to you:
Faster Approval + Proven Quality
Our offer to you:
Faster Approval
+
Proven Quality!
HOW WE CAN ASSIST YOU
Depending on your needs, we provide advice, support, and assistance throughout the entire process and across all regulatory areas. Alternatively, we can handle specific sections or assist your team with individual tasks.
QUALITY
We specialize in building and maintaining effective quality management systems that comply with industry standards, including ISO 13485, 21 CFR 820, and AQAP-2110. We focus on balancing rigorous quality standards with streamlined process optimization.
REGULATORY
We guide you through the complex global regulatory requirements for medical devices. Together, we develop customized regulatory strategies to ensure a seamless market entry for your products.
TECHNICAL
We provide the essential technical documentation for your medical devices in full compliance with strict regulatory requirements (Regulation (EU) 2017/745, 21 CFR 800 ff.).
Our commitment: manageable risks and precise documentation for an efficient approval process.
Our commitment: manageable risks and precise documentation for an efficient approval process.
CLINICAL
Our expertise in Clinical Affairs includes precise clinical evaluations and comprehensive post-market surveillance. Our goal is to ensure the highest quality for your products throughout their entire lifecycle.
DIGITAL
With us by your side, you can rely on a seamless approval process for your software as a medical device. We support you from regulatory classification through standards-compliant development to ensuring information security and data protection.
HOW WE CAN ASSIST YOU
Depending on your needs, we provide advice, support, and assistance throughout the entire process and across all regulatory areas. Alternatively, we can handle specific sections or assist your team with individual tasks.
QUALITY
We specialize in building and maintaining effective quality management systems that comply with industry standards, including ISO 13485, 21 CFR 820, and AQAP-2110. We focus on balancing rigorous quality standards with streamlined process optimization.
REGULATORY
We guide you through the complex global regulatory requirements for medical devices. Together, we develop customized regulatory strategies to ensure a seamless market entry for your products.
TECHNICAL
We provide the essential technical documentation for your medical devices in full compliance with strict regulatory requirements (Regulation (EU) 2017/745, 21 CFR 800 ff.). Our commitment: manageable risks and precise documentation for an efficient
approval process.
CLINICAL
Our expertise in Clinical Affairs includes precise clinical evaluations and comprehensive post-market surveillance. Our goal is to ensure the highest quality for your products throughout their entire lifecycle.
DIGITAL
With us by your side, you can rely on a seamless approval process for your software as a medical device. We support you from regulatory classification through standards-compliant development to ensuring information security and data protection.
ABOUT US
As an integral part of HP Medizintechnik GmbH, we have been actively involved in the approval and regulatory support of products in medical technology, life sciences, and healthcare since 1979. This extensive experience allows us to provide tailored solutions without compromising on quality or efficiency. |
New products, evolving requirements, emerging trends, and competitors—our industry is incredibly dynamic. At the same time, medical devices must, by definition, always meet the highest quality and safety standards.
The key to successful regulatory affairs management lies in balancing all these factors while maintaining a focus on profitability!”
Sandro Schmalzl
Managing Partner
HP Medizintechnik GmbH
“Unfortunately, for a long time, we couldn’t find anyone who could adequately manage this for us. As a result, we had to gradually develop the necessary expertise ourselves. In 2023, we decided to share this knowledge and make it available to other manufacturers.
This led to the founding of HP Med Consulting, built on the comprehensive expertise accumulated over the past four decades.”
Dr. Helmut Herz
Managing Director and Owner
HP Medizintechnik GmbH
HP Med Consulting - more than just advice.
HP MED CONSULTING: OVER 40 YEARS OF EXPERIENCE, EXPERTISE AND RESULTS!
“Efficient approval of medical devices ensures that patients gain fast and cost-effective access to safe treatments.
That is what we do!”
Christoph Sing
Managing Director
HP Med Consulting
Accordingly, we see it as our mission to guide your innovation swiftly through the regulatory approval process.
Whether developing customized regulatory strategies, establishing effective quality management systems, or preparing and supporting your audits –
you can count on us!
Compliance is mandatory.
Complexity is not!
Compliance is mandatory.
Complexity is not!
All key information about us, our areas of expertise, and our offerings can be found at a glance in our free flyer.
WHAT SETS US APART
#1
We are medical device manufacturers ourselves!
We understand not only the regulatory requirements but also the complexities of processes and related business challenges.
#2
We treat your approval process as if it were our own.
That’s why we build on what already exists, rather than reinventing the wheel.
#3
We see ourselves as your support, not just consultants!
We stand by your side whenever you need us.
#4
Expertise, experience & cutting-edge technology:
Our team of Regulatory Affairs experts uses all its know-how and the latest technologies to ensure fast results and
efficient processes.
OUR CLIENTS
We already work with medical device manufacturers of all sizes—primarily with medium-sized companies and startups, mainly from the German-speaking region.
Custom Surgical
Custom Surgical verbindet analoge Mikroskope mit Smartphones und ermöglichen es Augenärzten auf diese Weise, ihre Eingriffe einfach digital aufzuzeichnen und telemedizinische Anwendungen zu nutzen. Wir haben den Zulassungsprozess dieser innovativen Technologie von Beginn an begleitet und u.a. den Aufbau aller notwendigen Dokumente, die klinische Bewertung und die Audits betreut. Custom Surgical bietet inzwischen vier Produkte an. Diese sind derzeit bereits in über 70 Ländern weltweit bei Augenoperationen im Einsatz!
Mango Medical
Mango Medical revolutioniert die Behandlung von Knochenbrüchen:
Mit Hilfe künstlicher Intelligenz erstellt die eigens entwickelte Software präzise, schnelle und verständliche präoperative Pläne für die chirurgische Behandlung von Knochenfrakturen. Die Technologie zielt darauf ab, die Genauigkeit und Geschwindigkeit der Vorbereitung zu verbessern und so die Ergebnisse für Patienten zu optimieren und gleichzeitig die Prozesse für behandelnde Chirurgen zu vereinfachen.
Wir haben Mango Medical vor allem beim Aufbau des Qualitätsmanagementsystems gemäß ISO 13485 sowie bei der Erstellung der erforderlichen Prozesse und Dokumente, basierend auf den Anforderungen der IEC 62304 („Medizingeräte-Software – Software-Lebenszyklus-Prozess“) vollumfänglich beraten und unterstützen dürfen.
MACS
MACS bietet umfassende Serviceleistungen rund um vielfältige elektronische Anwendungen: von LED-Technik über Softwareentwicklung bis hin zu Medizinprodukten.
Wir betreuen bei MACS das Qualitätsmanagementsystem gemäß ISO 13485 und begleiten das Team bei den externen Zertifizierungs- und Überwachungsaudits durch die benannte Stelle. Darüber hinaus unterstützen wir MACS bei der Aktualisierung des Risikomanagementsystems gemäß ISO 14971 und dürfen bei den regelmäßig stattfindenden Kundenaudits unseren Beitrag leisten.
LOST IN REGULATION?
NO PROBLEM.
WE ARE HERE TO HELP!
Book your initial consultation today.
| HP MED Consulting GmbH | Bruckmannring 19 Germany | Phone +49 89 – 453 519 467 |
HP MED Consulting GmbH
Bruckmannring 19
D-85764 Oberschleissheim
Germany
Telefon +49 176 246 143 22
info@hp-med.consulting
www.hp-med.consulting
Telefon
+49 (89) 45 35 19 4 -50
info@hp-med.com
Öffnungszeiten
9:00 – 16:00 Uhr