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Our products boost your medical device market access and ensure a smart technical documentation

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Discover Our Portfolio

Get immediate access to your templates, book an appointment for an individual or group online training or take advantage of one of our services. Just contact us and we’ll get in touch with you at short notice.  

 

Check out what we can do for you and join the StraightForward Academy! 

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Templates

With our Templates documentation is finally fun.  Compliance with regulatory and normative requirements has never been easier. 

Online Tutorial

Trainings

Our Trainings equip you with the theoretical foundation and knowledge to get your product compliant onto your target markets. 

Working from Home

Services

Our Services provide you with hands-on support from our experts. Direct support for your questions or for challenging tasks.

What Clients Say

"Your in-depth knowledge of medical device development, especially in the areas of bio-compatibility, cleaning and sterilization processes, including the respective regulatory requirements, represent a great added value for every project."

About Us

We are a team of experienced consultants from the medical device and life science industry and are committed to provide you with the perfect external support. 

 

Our passion, experience, integrity & lifeblood for your safe and premium quality products.   

 
Satisfied Customers / Straight Forward. 

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Meet Our Team

Michael Hottner

Michael
Hottner

Vektorgrafik: Kreis
R&D Design Contrls and Project Management

R&D Design Controls and Project Management

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CE-Certifications and US FDA 510(k) Submissions

CE-Certifications and US FDA 510(k) Submissions

Vektorgrafik: Kreis
Biological Evaluations

Biological Evaluations

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Michael Bertram

Michael
Bertram

Vektorgrafik: Kreis
Cleaning, Disinfection, Sterilization

Cleaning, Disinfection, Sterilization

Vektorgrafik: Kreis
Process Validations

Process Validations

Vektorgrafik: Kreis
ISO 17664 & ISO 15883

ISO 17664 & ISO 15883

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Kristin Schwamborn

Kristin
Schwamborn

Vektorgrafik: Kreis
eCommerce & Business Development

eCommerce & Business Development

Vektorgrafik: Kreis
Networking & Collaboration

Networking & Collaboration

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Expanding our Portfolio

Expanding our Portfolio

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