Our mission

Our mission at Overbo&Associates is to leverage the extensive expertise of our seasoned professionals in quality management, quality assurance, regulatory affairs and clinical affairs to provide expert guidance and support to our clients. We are dedicated to helping our clients successfully navigate and adhere to the rigorous regulatory standards mandated by the FDA, EU MDR, and other international regulatory bodies, ensuring the highest levels of quality and compliance in their operations.

Get Started

Our Services

We can help you implement quality and regulatory processes,supplement projects, perform reviews before you submit your documentation to the competent authorities, conduct internal and supplier audits and train your staff on a variety of topics.

QUALITY MANAGEMENT

  • Risk-based QMS implementation
  • Design Controls
  • ISO 13485
  • ISO 17025
  • ISO 15189
  • ISO 14971

COMPUTER AND SOFTWARE VALIDATION

  • Computer System Validation (CSV)
  • Computer Software Assurance for Production and Quality System Software
  • Software development according to 62304

REGULATORY REVIEWS

  • 510K, Technical file and dossier review
  • Post-inspection remediation and response to authorities/NB
  • Clinical Evaluation Reports
  • Post Market Clinical Follow Up and clinical support

COMPLIANCE ASSESSMENT AND AUDITING

  • QMS compliance gap assessments
  • DHF reviews
  • Internal audits
  • Supplier audits

TRAINING

  • Training:
  • Custom tailored training and material.
  • In-person or virtual

The support and expertise you need

Whether you need to supplement your team with specific skills, or need support implementing or reviewing quality and regulatory processes, make Overbo&Associates your trusted partner in all Quality and Regulatory matters.

Contact us today to explore how we can assist you.

Contact Us

Location:

Minnetrista, MN 55364 - USA

Email:

info@overboconsulting.com

Call:

+1 (952) 797 2287

Loading
Your message has been sent. Thank you!