About us

About us

About Qualitas   Quality starts with a quality mindset. It grows with attention to detail and persistence. Qualitas Professional Services was founded by Lena Cordie, who began consulting for medical and dental device manufacturers in 2014, after working for 10 years in quality, regulatory and operations for a medical device manufacturer.  It was—and still is—Lena’s vision to bring quality practices and standards to businesses and organizations of any size. Quality is measured in dedication and effort, not size. Qualitas’ services span all aspects of quality management systems for the healthcare industry and medical device manufacturers. We offer core strengths in the following areas:

  • Quality systems (ISO 13485:2016)
  • Regulatory compliance (FDA QSR, EU MDD, MDSAP, and upcoming EU MDR changes)
  • Risk management (ISO 14971)
  • Healthcare and medical device standards (ISO 17664 etc.)
  • Unique Device Identification (UDI) & labeling requirements
  • FDA GUDID submissions & GMDN code searches
  • Software validation

We tailor each process and system to the individual client, applying our in-depth knowledge and vast experience to deliver the right solution. It begins with a question: “Tell me what you do.” From there, our team of specialists apply their skills in the areas where you need our help:

  • Identify and implement user and regulatory requirements
  • Apply hands-on project planning and management
  • Develop documentation and reviews
  • Design compliant labels
  • Validate software (IQ/OQ/PQ and 21 CFR Part 820)
  • Collate, review, and product data for UDI submissions
  • Incorporate UDI and barcode information onto medical device product labels
  • Conduct quality system gap analysis
  • Provide hands-on training for all processes and systems

Taking the first step is the most important. When you’re ready to infuse excellence throughout your organization—in thought and practice—contact Qualitas.

Let’s explore the “what if…” potential together.