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Our Products

The StraightForward Academy provides you with an extensive portfolio around your medical device registrations: 

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

Our Trainings equip you with the theoretical foundation and knowledge to get your product compliant onto your target markets. Get the expertise you need, when you need it. 

Our Services provide you with hands-on support from our experts. The services range from individual consulting to simulated use testing of your products in a clinical environment.  

Get maximum support from us with our Bundles. They include a comprehensive toolkit around an individual medical device subject area. 

 

 

Discover the benefits of StraightForward Academy: 

 

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! 

Medical Device Technical Documentation Templates
Trainings
Medical Device Consulting Services
Medical Device Consulting Bundles
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Services

You are a start-up with very limited resources? You have a unique problem and need external expertise? Entrust us or one of our partners. We help you with direct answers via consulting or with hands-on-support by one of our experts or test labs.

Direct support for your questions or for challenging tasks. Online, under short notice and reliable. 

Find out how we can support you! 

 Bundles

You are striving for efficiency and want to achieve the best results?

 

Check out our bundles! They include a comprehensive toolkit around an individual medical device subject area.  

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Vektorgrafik: Bilderrahmen

Templates

Documentation is finally fun! 

Find a selection of templates ranging from verification forms to checklists for smart compliance with regulatory requirements – just fill out the templates and reference your evidence documentation. 
 
Compliance for regulated products has never been easier. 

Trainings

Take part in one of our regular trainings, or book your individual appointment. Get the expertise you need, when you need it. 

Our online trainings will provide you with a theoretical foundation and also give you the opportunity to ask your individual questions. As the training is led by a subject matter expert, you’ll be in competent hands. 

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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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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

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Process Validations

Process Validations

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ISO 17664 & ISO 15883

ISO 17664 & ISO 15883

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Kristin Schwamborn

Kristin
Schwamborn

Vektorgrafik: Kreis
eCommerce & Business Development

eCommerce & Business Development

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Networking & Collaboration

Networking & Collaboration

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Expanding our Portfolio

Expanding our Portfolio

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Newsletter

We are continuously expanding our product portfolio - subscribe to stay up to date!

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