Outsourced Quality Assurance to Jump Start Your QMS


Don't spend thousands in a quality engineer. We have a quick, compliant, and cost-effective solution. Boulder iQ, an experienced consulting group in the Boulder area, has developed a uniquely responsive OutSourced™ Quality Assurance Program. This program jump starts your QMS, with the required procedures and time-saving forms and checklists. And, helps you manage the system to keep pace with your product launch timelines.

Outsourced Quality Assurance Services

Outsourced QA Service Management Functions Expertise


The Boulder iQ team, with at least one of its consultants dedicated to you, will provide the QA management functions for your start-up company. Implementation of the OSQA program means that you do not have to hire a fulltime QA person. Boulder iQ will manage your QA for a fraction of the cost of an FTE!

  • Developing & Writing

  • Supplier Evaluation & Controls

  • Technical Filing & FDA Submissions Writing

  • Risk Analysis Mitigation

  • Design Management

  • Production & Processes

  • Distribution

  • Complaint & CAPA Management

  • Quality System, Training, Audits & Remediation

Why Choose Boulder iQ


Boulder iQ conducts QA and Compliance activities on behalf of your company to ensure that all quality performance and regulatory requirements are continually met.

Cost Effective

For a fraction of the cost that you would have to pay an in-house QA associate, including salary and benefits, you will get a QA expert to manage your Quality System, supported by the full Boulder iQ team, helping to ensure that you have the right skills at the right time – whenever you need them. We bill our services on a monthly retainer, making it easier to budget.

Trustworthy

Boulder iQ has built its reputation on years of providing the best in regulatory services for medical device companies. We work with FDA and with international regulatory bodies to ensure that your company and your device are represented at your best. We often teach at Quality and Regulatory professional organization workshops and conferences. You will sleep easier, knowing that you are in the good hands of trusted Quality and Regulatory experts.

Experienced Consultants

Our consultants have together worked 90 years in both the private sector and for FDA. We know how things get done in a regulated industry, and we know the people who can make things happen in all the right ways for you.

Full Team Expertise

Together we cover the gamut of QA/Regulatory needs — versus one QA person at a facility who usually has strengths in only a portion of QA areas. You will have access to the full Boulder iQ team so that when specific skills are required or when more than one individual is needed to resolve an urgent task, the appropriate resources will be made available to you.

Other Ways to Improve Quality Control


If you have an existing Quality Management System, we can conduct a QMS audit to identify gaps in the existing system. With more than 400 audits performed by Boulder iQ staff, we can provide an efficient yet thorough gap analysis at your facility.

Based on the audit findings, Boulder iQ personnel will suggest changes to your current quality system documentation — for compliance as well as for ease of use.

To help you get your products to market in a timely manner, Boulder iQ provides personnel with proven success in writing regulatory submissions, including Technical Files for CE Marking your product, 510(k) and PMA submissions, and IDEs if required.