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.
Profile​
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Master & Diploma in Medical Engineering
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Certified Regulatory Affairs Manager International
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Member of Regulatory Affairs Professional Society
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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.
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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.
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Just give me a task and I get it done – Straight Forward.
Expertise Areas​​
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R&D Design Controls and Project Management
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CE-Certifications and US FDA 510(k) Submissions
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Biological Evaluations
Additional experiences
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Sterile Packaging Validations
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Toxicological Assessments
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Risk Management
Profile​
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Reprocessing Expert for ISO 17664 & ISO 15883
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Process Validation Specialist
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Regulatory Affairs Manager & Internal Auditor
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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.
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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​​
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Cleaning, Disinfection, Sterilization
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Process Validations
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ISO 17664, 17665 & ISO 15883
Additional experiences
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Regulatory Affairs Manager & Internal Auditor
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Ethylene Oxide Sterilization
Profile​
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Online Editor
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Master in Cultural Management & Education​
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.
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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​​
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eCommerce & Business Development
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Networking & Collaboration
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Expanding our Portfolio
Additional experiences
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Adult Education
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Public Relations
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Intercultural Competences
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