Quality Systems Consulting

We see this all the time. The most common reason is that a previous consultant or employee dropped off a QMS that they used at a previous company. More often than not, that QMS was designed for a large mature company and isn’t suitable for a small or early-stage company.

Yes! We offer a foundational set of QMS templates designed specifically for medical device startups and small teams. But more importantly, we help you use them effectively.

Templates alone won’t make you compliant. A Quality Management System isn’t just a stack of documents, but a framework that shapes how your organization operates and demonstrates that you’re in control. We work with you to tailor the system to your products, processes, and stage of development so that it’s both compliant and practical.

If you’re starting from scratch, we can help you get there.

Our client work is confidential, so we can’t name names, but here’s a look at the kinds of products we’ve helped bring to market.

• •  Diagnostics
    • Infectious diseases
    • ELISA
    • Latera flow
  • Women’s health
    • Menstrual cup and disc
    • Contraceptive
    • Fertility assays
  • Orthopedics
    • Surgical screws
    • Spinal implants
  • Allografts and tissue products
    • Orthopedics
  • Catheters
    • Urology
    • Cardiac
    • Cerebral
  • General surgery
    • Scalp cooling system
    • Scalpels and tools
  • Dermatology and aesthetics
    • Microneedle
    • Cannulas
  • Contract Manufacturers and assemblers

You might be asking, “Ya, but are you familiar with my technology?”

Probably!

Here is a list of the processes we have experience with:

• • Bulk formulations, aliguoting, filling, labeling
  • Molecular biology
  • Kitting and assembly
  • Electromechanical devices
  • Injection molding & extrusion
  • CNC lathe and stamping
  • Sterile products
  • Tissue banking and cell banking
  • Cell culture and microbiology
  • Nanotechnology and fluorophores
  • Textiles

I refer to our services as “light regulatory”. We are not 510(k) or PMA submission experts, although we can refer you to one. What Regulatory do we do?

• • Product code search
  • Regulatory roadmap and cost estimates
  • Label review
  • Recalls and removals
  • Establishment Registration and Device Listing
  • UDI and GUDID
  • FDA database research

For more discussion on the difference between Regulatory Affairs and Quality Assurance, see our blog post.

We have developed flexible approaches for different situations. If you have quality assurance personnel, we partner with them to implement the plan. If not, Qualomics can work independently. While we are capable of working autonomously, we strongly believe that involving your team leads to the best outcome. This collaboration helps build your internal expertise and ensures the quality system is fully integrated and sustainable.

Yes, absolutely. We are proud of what sets us apart. Unlike many competitors who may be former executives out of touch with daily realities, we provide direct, hands-on support. We work alongside you to tackle the day-to-day tasks of quality management, including document control, corrective action implementation, complaint handling, and all other aspects of ISO 13485 and 21 CFR 820 requirements. We always keep an eye on how our plans impact your operations.

Absolutely. Our team includes expertise from executive down to associate level, enabling us to provide high-level strategic guidance, such as strategic planning for your quality system, in addition to hands-on execution.

This is one of the most common questions we get and unfortunately, there’s no one-size-fits-all answer.

Transferring SOPs and forms to your team takes almost no time at all. But receiving the documents is just the beginning. Implementation starts when you begin using those SOPs and forms to generate records that show how your organization actually operates.

There are two ways to think about a QMS:

• • As a collection of documents you can purchase as templates

  • Or as a management framework that guides and documents your real-world practices

The first is quick. The second takes planning, alignment, and effort and that’s where the real value (and time investment) comes in. Projects can take as little as 3 months, but most are closer to a year for full implementation and generation of records.

We charge a transparent hourly rate for the work performed. You receive a monthly report detailing our time and tasks. Based on our experience, we do not accept fixed-price consulting projects. Quality system implementation involves many variables outside our direct control, making fixed pricing impractical and often leading to unexpected issues. Our hourly approach ensures flexibility and that you only pay for the support you need.

Our gap assessments and audits are fixed-price and quoted based on the scope of the audit and your operations.