Qualitas Compliance, LLC is a women-owned business strategically located in Raleigh, NC minutes from the Raleigh Durham Airport and the Research Triangle Park. Qualitas focuses on successfully navigating the ever-changing quality and regulatory waters of the medical device industry. We exist to help our clients move quickly through the compliance aspects of establishing their business along with moving their products through the quality / regulatory paths in preparation for market entry.
We understand what it takes to set up a company’s quality system for compliance with ISO 13485, ISO 9001, ISO 14971, GMP, and FDA 21 CFR Part 820 along with compiling FDA ready regulatory submissions to move your product through the compliance channels.
Whether you need assistance in writing a single Standard Operating Procedure (SOP), setting up a complete quality management system from scratch, conducting risk management activities, generating a gap analysis, assisting with the Corrective & Preventative process, training, or conducting audits, our knowledgeable and talented team is here to help you achieve compliance!
About the Founders
Qualitas Compliance Cofounders are industry recognized professionals that come from a medical device development / manufacturing background and have extensive experience in bringing products through the quality and regulatory channels in preparation for market entry. The cofounders have successfully built ISO 13485 quality procedures and systems, written FDA compliant documentation / submissions, and are certified auditors.
- Amy Jones, Co-founder
- Sarah Evans, Co-founder
Frequently Asked Questions:
Who does Qualitas work with?
Qualitas works with a range of diverse clientele:
- Startup & mid-size medical device companies
- Manufacturing companies
- Startup & mid-size life sciences companies
- Startup & mid-size consumer health companies
- University spinoff companies
How do I get a quote and how are your quotes structured?
Qualitas offers flexible quotes to meet our diverse clientele needs. During the initial meeting / conference call, Qualitas will gain an understanding of our client’s needs and objectives and will provided a detailed quote thereafter. Our quotes are structured based on milestones and depending on the length of the project and complexity, our quotes can be fixed price or based on an hourly rate.
What if I just need one document written?
Not a problem! Qualitas can help and is dedicated to even the smallest job. Whether you need one document written or an entire quality system built from scratch, Qualitas treats all of our clients as strategic partners and we look forward to benefiting your business.
How do you handle clients that are out of state?
Qualitas welcomes clients from the entire USA, Canada and Europe. It is easy for us to work with these clients as communication is down via WebEx, Conference Calls, and onsite as needed. In addition, we do specific desktop audits through electronic file transfers to save time and cost for our client.
What type of documents can your write?
Qualitas Compliance can write standard operating procedures for your business along with quality manuals. In addition, Qualitas Compliance can write product specific documentation to meet your compliance and FDA needs. Qualitas Compliance also writes FDA submissions.
How do you handle confidentiality?
At Qualitas Compliance confidentiality is paramount! When signing onto a project a mutual confidentiality agreement is put into place. The confidentiality agreement covers the transfer of all documents.
Can you represent my company at FDA?
Yes, Qualitas can represent your company in FDA meetings.
Can you provide industry references that speak to your experience?
Yes, Qualitas Compliance can provide references that speak to our Quality / Regulatory background, documentation, as well as project management.