Medical Device

Labtopia provides medical device consulting services to U.S. Food and Drug Administration (FDA) regulated medical device companies. Labtopia Solutions provides ISO 13485 auditing and consulting services as well as 21 CFR Part 820 and 21 CFR Part 11 compliance solutions. Services include:

  • Medical Device GMP Audits & Gap Assessments
  • ISO 13485 Audits & Gap Assessments
  • Quality System Standard Operating Procedures
  • Vendor Qualification Audits
  • Complaint Investigations
  • Part-time Quality Assurance Support

Based in Houston, TX, Labtopia is ideally located to support the technology emerging from the world-renowned Houston Medical Center. Labtopia specializes in providing Quality Systems Regulations support to small to mid-sized medical device companies. Additionally, Labtopia provides interim quality system and regulatory support to medical device start-ups.

As a member of the Gulf Coast Medical Device Manufacturers organization, Labtopia’s network of professionals is able to provide comprehensive services to the medical device industry. Additional services include regulatory filings and validations.

Additionally, Labtopia is able to provide comprehensive technical and scientific support within the medical device industry.

  • Labtopia Staffing provides staffing and recruiting services for engineers, laboratory, manufacturing and quality personnel.
  • Laboratory Informatix provides informatics services for planning, development and implementation of quality related databases, such as LIMS, customer complaint systems, training systems and corrective and preventive action systems.
  • Labtopia Training provides a full slate of training courses designed for management and technical personnel.