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OUR TEAM

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

 

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

 
Satisfied Customers / Straight Forward. 

Straight Forward Medical Device Consulting Theme
Michael Hottner: Managing Director and Senior Consultant R&D Project Management and Regulatory Affairs

Profile

  • Master & Diploma in Medical Engineering

  • Certified Regulatory Affairs Manager International

  • Member of Regulatory Affairs Professional Society

  • 15+ years experience in R&D Project Management and Regulatory Affairs

Michael Hottner

Managing Director

Senior Consultant R&D Project Management and Regulatory Affairs

My heart's beating for two different worlds: Product Development and Regulatory Affairs. I am both a passionate engineer and a regulatory geek. This enables me to easily navigate between regulatory paperwork, innovative product concepts and fast paced R&D projects. So I definitely know how to connect the dots from early design prototypes to the final page of a regulatory submission.

My work experience covers more than 15 years in multiple positions from demanding coordinational tasks like Project Management, Project Coaching, M&A Integrations, Regulatory Affairs Management down to really profound nerdy subject matters tasks like biological evaluations, toxicological risk assessments, clinical evaluations, clinical trial management, submission compilation and technical documentation creation or remediation.

Just give me a task and I get it done – Straight Forward.

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Expertise Areas​​

  • R&D Design Controls and Project Management

  • CE-Certifications and US FDA 510(k) Submissions

  • Biological Evaluations

Additional experiences

  • Sterile Packaging Validations

  • Toxicological Assessments

  • Risk Management

Michael Bertram: Senior Consultant Reprocessing, Cleaning, Disinfection & Sterilization

Profile

  • Reprocessing Expert for ISO 17664 & ISO 15883

  • Process Validation Specialist

  • Regulatory Affairs Manager & Internal Auditor

  • 12+ years experience in Cleaning, Disinfection and Sterilization Validations

Michael Bertram

Senior Consultant Reprocessing, Cleaning, Disinfection & Sterilization

I am your guy for the ‘dirty stuff’. No matter if it shall be clean, disinfected or sterile, my ultimate goal is an SAL of 10-6. If you have no clue what this means your should better join one of my trainings.

14 years ago I started my career as a service technician for steam sterilizers, so I really know from the scratch how such devices work. After various reprocessing related positions with small, medium and multinational companies I founded SteraClean in 2017. Since then I supported numerous companies with reprocessing consulting, process validations and hands-on-project work.

Expertise Areas​​

  • Cleaning, Disinfection, Sterilization

  • Process Validations

  • ISO 17664, 17665 & ISO 15883

Additional experiences

  • Regulatory Affairs Manager & Internal Auditor

  • Ethylene Oxide Sterilization

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Kristin Schwamborn: eCommerce and Business Development Manager

Profile

  • Online Editor

  • Master in Cultural Management & Education​

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Kristin Schwamborn

eCommerce & Business Development Manager

I am the strategic and executing power behind the StraightForward Academy. I am driven to set up a platform that enables MedTech companies worldwide to directly access and benefit from the StraightForward Consulting expert network.

You are a device manufacturer and need external support? You have a product idea or you would like to collaborate?  

 

Don’t hestitate to contact me to have a virtual coffee.

Expertise Areas​​

  • eCommerce & Business Development

  • Networking & Collaboration

  • Expanding our Portfolio

Additional experiences

  • Adult Education

  • Public Relations

  • Intercultural Competences 

 
 
 
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