Heikki Pitkänen
HP

Heikki Pitkänen

Linkedin Profile
CEO & Founder, Digital Regulatory Runways at Lean Entries | Tampere, Pirkanmaa, Finland
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About Heikki Pitkänen

  • Heikki Pitkänen, as the CEO and Founder of Lean Entries, is at the forefront of revolutionizing how complex regulatory frameworks are navigated within the health tech industry. With a deep commitment to simplifying intricate regulations, Heikki has harnessed the power of the proprietary ENTRIES platform...
    Heikki Pitkänen, as the CEO and Founder of Lean Entries, is at the forefront of revolutionizing how complex regulatory frameworks are navigated within the health tech industry. With a deep commitment to simplifying intricate regulations, Heikki has harnessed the power of the proprietary ENTRIES platform to create minute digital runways that provide instant, actionable knowledge for users who may lack extensive experience in regulatory affairs. His innovative approach not only demystifies compliance but also accelerates the path to market for health tech solutions, ensuring that critical innovations can reach those in need more swiftly. Since joining the Labquality family of companies in February 2021, Heikki has spearheaded several key projects aimed at enhancing the usability and accessibility of regulatory information. His expertise in project management, product development, and quality systems has been instrumental in driving the development of tailored solutions that meet the stringent demands of the biomedical engineering sector. By leveraging his background in R&D and service design, Heikki has positioned Lean Entries as a pivotal player in the health tech landscape, where the intersection of technology and regulation is increasingly vital. Heikki’s passion for transforming the regulatory landscape is matched by his extensive knowledge in biomaterials and testing, allowing him to guide teams through the complexities of validation processes. As Lean Entries continues to expand its influence, Heikki remains dedicated to empowering organizations with the tools they need to navigate regulatory challenges confidently, fostering innovation and ensuring compliance in a rapidly evolving industry.
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  • Heikki Pitkänen Work

    • Senior Expert, Regulations & Quality at Aurevia in February 2021 to Present
    • CEO & Founder, Digital Regulatory Runways at Lean Entries in October 2016 to Present
    • Senior Specialist (on demand) at SGS in October 2016 to August 2022
  • Heikki Pitkänen Education

    • Tampere University of Technology, M.Sc., January 1997 to January 2002
    • Universitat Politècnica de València (UPV), Industrial Management, January 2000 to January 2001
  • Heikki Pitkänen Skills

    • Project ManagementMedical DevicesFDA
      ISO 13485Quality AssuranceRegulatory AffairsBiotechnologyR&DProduct DevelopmentQuality SystemOrthopedicBiomaterialsDesign ControlTestingBiomedical EngineeringCAPAValidationManagementEntrepreneurshipLean StartupService DesignResearch and Development (R&D)

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  • About Heikki Pitkänen's Current Company

  • Frequently Asked Questions about Heikki Pitkänen

    • What is Heikki Pitkänen email address?
      Email Heikki Pitkänen at h***s@hotmail.com and h***n@leanentries.com. This email is the most updated Heikki Pitkänen's email found in 2025.
    • How to contact Heikki Pitkänen?
      To contact Heikki Pitkänen send an email to h***s@hotmail.com or h***n@leanentries.com.
    • What company does Heikki Pitkänen work for?
      Heikki Pitkänen works for Lean Entries
    • What is Heikki Pitkänen's role at Lean Entries?
      Heikki Pitkänen is CEO & Founder, Digital Regulatory Runways
    • What is Heikki Pitkänen's Phone Number?
      Heikki Pitkänen's phone (**) *** *** 217
    • What industry does Heikki Pitkänen work in?
      Heikki Pitkänen works in the Medical Device industry.

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