RegulatoryThinking Services

Optimize Regulatory Compliance and GROW YOUR Business

Looking to streamline your processes and stay ahead in the industry? RegulatoryThinking Services by SLQ GmbH, MedDEV News and the "RegulatoryExperts" offer tailored solutions to transform YOUR operations. Our approach combines the latest digital tools with expert guidance, the knowledge database "RegulatoryWiki" and the Publication Services "MedDEV News", specifically designed for the Healthtech sector. Imagine a seamless workflow, enhanced efficiency, and compliance with ease, all enabled by our innovative solutions. Take the first step towards operational excellence. Explore RegulatoryThinking Services and see how we can grow your business. Get in touch now!

Learn More about Regulatory Thinking

Services

Regulatory Compliance Training based on the principles of RegulatoryThinking

RegulatoryThinking: Learn how to integrate the principles of RegulatoryThinking into your "work4certification" and "going2market" strategies.

eQMS Implementation and automated solutions

Streamline your Quality Management System and your Technical Documentation with our tailored digital eQMS tools and solutions - powered by RegulatoryThinking. All our tools and instruments comply with relevant ISO standards and MDR / IVDR. We also provide eFDA tools to enter the US market.

Regulatory Consulting and Hands on Services by RegulatoryThinking Experts

Benefit from expert guidance and hands-on support for navigating healthtech regulations. All our experts are trained in RegulatoryThinking. They are also experts in regulatory integrated business planning.

Send us an email. We will contact you.

Regulatory AI by surgeSupply.org

Discover our AI tools, courtesy of Regulatory Thinking, or join Chat GPT to enter the world of our open source ARMA AI platform.

RegulatoryAI - Intended Purpose Creator Regulatory AI - Classification Calculator

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Become a member of the RegulatoryThinking Community. The principles of RegulatoryThinking (R) are teached and trained by ETH Zürich (CAS Regulatory Thinking), the University of Applied Science Kärnten (part of the MAS Digital Dental Solutions), by the Medical Innovations Incubator (MII) Tübingen, the 4C Accelerator Tübingen and SA4RMA, the Swiss Accelerator for Regulated Market Access.

The RegulatoryThinking Comunity

SA4RMA is specifically designed to support healthtech startups and spin-offs in Switzerland during their market entry. Therefore, we offer RegulatoryThinking Packages or compliance and regulatory insight to accelerate YOUR time to market. Startups not based in Switzerland can also benefit from our network and services.

Prof. Dr. Jens Ulmer; SA4RMA - the Swiss Accelerator for Regulated Market Access

We provide training and education in RegulatoryThinking, focusing on the manufacturing and documentation of dental products (MAS Digitale Dentaltechnik). Our students benefit from an extremely streamlined workflow, powered by RegulatoryThinking eTools, which aids in securely navigating regulatory compliance and coordination.

Dietmar Schaffarczyk, Lecturer "Zahntechnische Qualitäts- und Prozessmanagement" University of Applied Science Kärnten

The regulatory requirements of the healthcare market as a strategic opportunity by integrating them in the business model development – that is the essence of Regulatory Thinking®. By conveying this mindset, we want to enable startups, industries, and academics to navigate the regulatory and business pathway of their medical innovations faster, more efficient and more sustainable.

4C Accelerator and Medical Innovations Incubator (MII), Tübingen

Regulatory Thinking (RT) is a methodological thinking approach to ensure translation of research and development into clinical solutions. It considers interests of the various stakeholders, e.g., health authorities but also patient interests. The main topics of the CAS are: Regulatory World; Regulatory Thinking; Road Map; Development Process: Pre-??clinical; Production (GMP); Development Process: Clinical; Approval / Post Market Activities; Success Factors.

CAS ETH in Regulatory Thinking, Berufsberatung.CH

Become a member of the RegulatoryThinking Community. The principles of RegulatoryThinking (R) are teached and trained by ETH Zürich (CAS Regulatory Thinking), the University of Applied Science Kärnten (part of the MAS Digital Dental Solutions), by the Medical Innovations Incubator (MII) Tübingen, the 4C Accelerator Tübingen and SA4RMA, the Swiss Accelerator for Regulated Market Access.

The RegulatoryThinking Comunity

SA4RMA is specifically designed to support healthtech startups and spin-offs in Switzerland during their market entry. Therefore, we offer RegulatoryThinking Packages or compliance and regulatory insight to accelerate YOUR time to market. Startups not based in Switzerland can also benefit from our network and services.

Prof. Dr. Jens Ulmer; SA4RMA - the Swiss Accelerator for Regulated Market Access

We provide training and education in RegulatoryThinking, focusing on the manufacturing and documentation of dental products (MAS Digitale Dentaltechnik). Our students benefit from an extremely streamlined workflow, powered by RegulatoryThinking eTools, which aids in securely navigating regulatory compliance and coordination.

Dietmar Schaffarczyk, Lecturer "Zahntechnische Qualitäts- und Prozessmanagement" University of Applied Science Kärnten

The regulatory requirements of the healthcare market as a strategic opportunity by integrating them in the business model development – that is the essence of Regulatory Thinking®. By conveying this mindset, we want to enable startups, industries, and academics to navigate the regulatory and business pathway of their medical innovations faster, more efficient and more sustainable.

4C Accelerator and Medical Innovations Incubator (MII), Tübingen

Regulatory Thinking (RT) is a methodological thinking approach to ensure translation of research and development into clinical solutions. It considers interests of the various stakeholders, e.g., health authorities but also patient interests. The main topics of the CAS are: Regulatory World; Regulatory Thinking; Road Map; Development Process: Pre-??clinical; Production (GMP); Development Process: Clinical; Approval / Post Market Activities; Success Factors.

CAS ETH in Regulatory Thinking, Berufsberatung.CH

Become a member of the RegulatoryThinking Community. The principles of RegulatoryThinking (R) are teached and trained by ETH Zürich (CAS Regulatory Thinking), the University of Applied Science Kärnten (part of the MAS Digital Dental Solutions), by the Medical Innovations Incubator (MII) Tübingen, the 4C Accelerator Tübingen and SA4RMA, the Swiss Accelerator for Regulated Market Access.

The RegulatoryThinking Comunity

SA4RMA is specifically designed to support healthtech startups and spin-offs in Switzerland during their market entry. Therefore, we offer RegulatoryThinking Packages or compliance and regulatory insight to accelerate YOUR time to market. Startups not based in Switzerland can also benefit from our network and services.

Prof. Dr. Jens Ulmer; SA4RMA - the Swiss Accelerator for Regulated Market Access

We provide training and education in RegulatoryThinking, focusing on the manufacturing and documentation of dental products (MAS Digitale Dentaltechnik). Our students benefit from an extremely streamlined workflow, powered by RegulatoryThinking eTools, which aids in securely navigating regulatory compliance and coordination.

Dietmar Schaffarczyk, Lecturer "Zahntechnische Qualitäts- und Prozessmanagement" University of Applied Science Kärnten

The regulatory requirements of the healthcare market as a strategic opportunity by integrating them in the business model development – that is the essence of Regulatory Thinking®. By conveying this mindset, we want to enable startups, industries, and academics to navigate the regulatory and business pathway of their medical innovations faster, more efficient and more sustainable.

4C Accelerator and Medical Innovations Incubator (MII), Tübingen

Regulatory Thinking (RT) is a methodological thinking approach to ensure translation of research and development into clinical solutions. It considers interests of the various stakeholders, e.g., health authorities but also patient interests. The main topics of the CAS are: Regulatory World; Regulatory Thinking; Road Map; Development Process: Pre-??clinical; Production (GMP); Development Process: Clinical; Approval / Post Market Activities; Success Factors.

CAS ETH in Regulatory Thinking, Berufsberatung.CH

Our Top Services & Pricing Guide

Open Access Documents & Essential Regulatory Support

Open Access: ARMA*

For emerging startups and spin-offs, we extend exclusive offers and pricing because we understand the journey – we've been there. Our support for startups and their innovative ideas is unwavering. We're dedicated to fostering a Regulatory Thinking® mindset, essential for navigating the regulatory landscape. Let us assist in integrating a tailored regulatory and certification strategy into your business blueprint. Become a part of our RegulatoryThinking® Community today! ARMA is provided by SLQ and SA4RMA - the Swiss Accelerator for Regulated Market Access.

Ask for YOUR open access document package.

Comprehensive guidance and assistance for regulatory compliance.

ISO 13485:2016 Flashcards

ISO Guidelines and Regulatory WIKI

AI based Regulatory Tools

* Accelerated Regulatory Market Approval

Popular

Regulatory Auditing Packages

EUR 350,- Starter Kit

Internal Audits, Supplier Audits, Certification Audits: Together with our partners we audit your QMS system and assess its compliance readiness

Our RegulatoryThinking experts conduct internal- and/or supplier audits to ensure your system's compliance readiness. Through collaborative workshops, we guide you towards achieving 100% compliance, certifying your system under GMP, GLP, ISO 9001, and ISO 13485 - together with our partner QS Services Ltd. We evaluate your Product File and Technical Documentation, supporting you throughout the certification process to uphold the highest standards of quality and regulatory adherence in your business.

Remote and/or on-site audits

Workshops including document packages

Certification services

Digital Tools and (AI based) Instruments

eQMS Basic Version: EUR 1.999,-

Regulatory, Certification Teaching, Coaching and Hands-on Services for the Healthtech Industry. We also offer and regulatory integrated business planning service called Regulatory Thinking (R). Our services are tailored for start-ups, SMEs and industry. We are specialized in providing tailored digital tools and instruments, such as eQMS, Compliance Navigator, LiSA - automated literature search, regulatory training calendars, supplier evaluation tools, eTD - Technical Documentation

Inform us how to customize our eQMS for you.

Discover the future of quality management with our unique eQMS! Tailored for flexibility, it's the first of its kind to seamlessly adapt to a range of regulations including MDR, IVDR, FDA, and ICH. Starting off strong with pre-filled, quality-controlled ISO 13485 QM-Documents, our system is built to grow with your needs. Experience transparency with our straightforward pricing, no hidden fees involved. Security is paramount in our design, ensuring your data stays protected. Customize it to fit your specific requirements. Enhance your clinical evaluation with plug-ins for ISO 14155 documents and Clinical Study Planning. Elevate your operations with our innovative (AI-based) tools like LiSA (Literature Search Automatization), SupplierCoach, DiDo-Tool, Compliance navigator and AI-based Classification. Join the (r)evolution in quality management systems and see how our eQMS can transform your business.

eQMS

Compliance Navigator

LiSA

Services FAQ

Who can benefit from your services?

Our services are tailored for start-ups, SMEs, and industry in the Healthtech sector.

ARMA: Kickoff Platform with Open Access to Plan and Initiate Your Business with ISO, MDR/IVDR/FDA Compliance from the Start. All Open Access Documents Seamlessly Integrate into RegulatoryThinking Systems and eTools. All Open Access Documents are Regulatory Controlled Documents.

What is ARMA and SA4RMA?

ARMA is an open spource platform, providing documents to kickstart your healthtech certification process. The document package is provided by the RegulatoryXperts from SLQ GmbH and SA4RMA - the Swiss Accelerator for Regulated Market Access.

Do you provide business planning services?

Yes, we provide Regulatory Thinking®, a comprehensive service that includes training, hands-on assistance, and tools for integrated business planning with a focus on regulatory compliance.

RegulatoryThinking means Regulatory Integrated Business Planning for the Healthtech Sector. Our RegulatoryThinking Tools: RegulatoryThinking Business Plan, RegulatoryThinking Canvas, RegulatoryThinking Reimbursement Strategies, RegulatoryThinking Compliance Navigator.

We also provide going2market services and work4certification services.

What tailored digital tools do you offer?

We provide a range of (AI-based) tools including eQMS, Compliance Navigator, LiSA for clinical evaluations and literature searches, regulatory training calendars, supplier evaluation tools, eTD for Technical Documentation, automated classification systems, and more.

eQMS without Subscription. No Hidden Fees. Content-First Approach: Pre-filled with ISO and Technical Documentation Basis Documents. Customizable to ISO, FDA, MDR, IVDR Requirements. Fully Flexible. Plugin Modules for Specialized Topics. Not a Cloud Solution, Installed on Your Own Server. Complete Control Over the System for the Customer. 24/7 Expert Support.

Contact Us Today

Need to navigate complex regulations and optimize your processes?

Our regulatory and certification services, including personalized teaching, coaching, and hands-on support, are here to help.

Elevate your Quality Management Systems with our unique eQMS tools, tailored for your business needs.

Ready for a change? Fill out the contact form below and let's get started on enhancing your operations today!

About us

SLQ Consultants GmbH is a leading provider of regulatory, certification teaching, coaching, and hands-on services for the Healthtech industry. With our expertise and tailored digital tools, we offer comprehensive solutions to start-ups, SMEs, and industry professionals.

Our team of experts specializes in delivering top-notch services like eQMS, Compliance Navigator, LiSA - automated literature search, regulatory training calendars, supplier evaluation tools, and eTD - Technical Documentation. We are committed to helping our clients navigate the complex regulatory landscape and achieve their business goals.

Headquarter
Sonnenstrasse 35
CH 8280 Kreuzlingen

Handelsregistereintrag
SLQ GmbH
Company ID: CHE-149.064.705
Handelsgericht Thurgau

Vertretungsberechtigte Personen
Geschäftsführer gemäss Eintrag im Handelsregisteramt Thurgau

Haftungsausschluss
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Die Urheber- und alle anderen Rechte an Inhalten, Bildern, Fotos oder anderen Dateien auf der Website gehören ausschliesslich der Firma SLQ GmbH oder den speziell genannten Rechtsinhabern. Für die Reproduktion jeglicher Elemente ist die schriftliche Zustimmung der Urheberrechtsträger im Voraus einzuholen.

Datenschutz
Gestützt auf Artikel 13 der schweizerischen Bundesverfassung und die datenschutzrechtlichen Bestimmungen des Bundes (Datenschutzgesetz, DSG) hat jede Person Anspruch auf Schutz ihrer Privatsphäre sowie auf Schutz vor Missbrauch ihrer persönlichen Daten. Wir halten diese Bestimmungen ein. Persönliche Daten werden streng vertraulich behandelt und weder an Dritte verkauft noch weiter gegeben.

In enger Zusammenarbeit mit unseren Hosting-Providern bemühen wir uns, die Datenbanken so gut wie möglich vor fremden Zugriffen, Verlusten, Missbrauch oder vor Fälschung zu schützen.

Beim Zugriff auf unsere Webseiten werden folgende Daten in Logfiles gespeichert: IP-Adresse, Datum, Uhrzeit, Browser-Anfrage und allg. übertragene Informationen zum Betriebssystem resp. Browser. Diese Nutzungsdaten bilden die Basis für statistische, anonyme Auswertungen, so dass Trends erkennbar sind, anhand derer wir unsere Angebote entsprechend verbessern können.

SLQ GmbH, Kreuzlingen, 02.05.2022

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