Devices and diagnostics we’ve supported
A sample of the medical devices and IVDs Qualomics has supported, organized by where they are used. Each area lists the product types and the manufacturing processes and technologies involved.
Brain and scalp
- Concussion detection
- Scalp cooling
- Dementia monitoring
Complex electromechanical · Stand-alone app · Home use designation
Mouth and jaw
- Endoscope
- X-ray sensor
- Mouthguard
Camera and software · Injection molding · Firmware without software · Commercial labeling
Skin
- Microneedle
- Sutures
- Cannula
Single-use sterile · Stainless steel · Sharpening and passivation
Heart, vessels, and kidneys
- Catheters
- Drug-coated balloon
- Image-guided biopsy
Combination product · Nanoparticle · Nitinol · Extrusion · Optics and software
Spine and bone
- Spinal implants
- Surgical screws
- Allografts
Tissue donation · CNC machining · Additive manufacturing · Passivation and coating · Sterilization
Muscles and joints
- Posture corrector
- LED pain relief
- Grip strength tester
- Wearable
Textile · Simple electronics without software · Electromechanical · Stand-alone app · Commercial labeling
Pelvic health
- Menstrual cup and disc
- Contraceptive
- Lubricant
Silicone injection molding · Formulations · Commercial labeling
Surgical site
- Scalpels
- Orthopedic instruments
- Instrument trays
- Surgical gloves and drapes
Tool and die, stamping, finishing · Multi-use and single-use sterile
Off the body
- Diagnostics
- Molecular and biological assays
- Laboratory equipment
- Instruments, automation, and robotics
- Hospital equipment
- Clamps, poles, and carts
Molecular and biological materials · Formulation · Assay validation · Complex electromechanical · Robotics
Brain and scalp
- Concussion detection
- Scalp cooling
- Dementia monitoring
Complex electromechanical · Stand-alone app · Home use designation
Mouth and jaw
- Endoscope
- X-ray sensor
- Mouthguard
Camera and software · Injection molding · Firmware without software · Commercial labeling
Skin
- Microneedle
- Sutures
- Cannula
Single-use sterile · Stainless steel · Sharpening and passivation
Heart, vessels, and kidneys
- Catheters
- Drug-coated balloon
- Image-guided biopsy
Combination product · Nanoparticle · Nitinol · Extrusion · Optics and software
Spine and bone
- Spinal implants
- Surgical screws
- Allografts
Tissue donation · CNC machining · Additive manufacturing · Passivation and coating · Sterilization
Muscles and joints
- Posture corrector
- LED pain relief
- Grip strength tester
- Wearable
Textile · Simple electronics without software · Electromechanical · Stand-alone app · Commercial labeling
Pelvic health
- Menstrual cup and disc
- Contraceptive
- Lubricant
Silicone injection molding · Formulations · Commercial labeling
Surgical site
- Scalpels
- Orthopedic instruments
- Instrument trays
- Surgical gloves and drapes
Tool and die, stamping, finishing · Multi-use and single-use sterile
Off the body
- Diagnostics
- Molecular and biological assays
- Laboratory equipment
- Instruments, automation, and robotics
- Hospital equipment
- Clamps, poles, and carts
Molecular and biological materials · Formulation · Assay validation · Complex electromechanical · Robotics
Case Study
QMS buildout to ISO 13485 certification
Situation
A company with several hundred employees makes a laboratory instrument that runs research use only (RUO) assays. Its business plan always included regulated products, and it was working toward ISO 13485 certification to support launching the instrument and its reagents as IVDs. Many of its staff came from medical device companies, so its existing processes and PLM system were based on ISO and FDA practices but had not been built to meet them. A large consulting firm was supporting the certification effort, but the team needed more specific, hands-on direction to complete the work.
Approach
Qualomics helped the team turn requirements into finished tasks. The project covered every area of the business, from facilities to document control, and the level of involvement matched the need. Areas already in good shape, such as document control, got a high-level review to confirm compliance without adding work. Process and software validation needed much more involvement. We started with process flow charts to identify which processes required validation, then provided validation plan templates, reviewed the team’s draft plans line by line, and followed up as they worked through the validation. The company’s own team did much of the work. Our role was to give them clear answers quickly so the team could keep moving.
Result
The company announced its ISO 13485 certification about seven months after Qualomics joined the project.
As a fast-growing, innovation-driven company, we needed to build a Quality Management System that could support our growth and ultimately achieve ISO 13485 certification, without creating unnecessary bureaucracy or processes that would slow the organization down.
Erica and the Qualomics team helped us refine and implement a Quality System that was tailored to how our company actually operates. She was extremely thoughtful about scope, risk, and approach, helping us focus our efforts where they mattered most. One of Erica’s biggest strengths was her ability to operate at both levels—thinking strategically about the overall system and our path to certification, while also diving deeply into the details when necessary to make sure the processes were compliant, practical, and sustainable.
The result was a Quality Management System that worked for our company and a successful ISO 13485 certification. Just as importantly, we ended up with a system that supports our continued growth and innovation rather than getting in the way of it.
More ways we’ve helped
Three shorter engagements
Fractional quality leadership
A small medical device company already held ISO 13485 and MDSAP certification. It outsources most of its manufacturing and performs final assembly in house. When its quality consultant moved on to other projects in 2024, Qualomics took over day-to-day quality management remotely and continues in that role today. The work covers complaints, nonconformances, CAPAs, and preparing for and responding to audits, some of which have closed with no findings. Along the way, we supported two 510(k) submissions, one for a significant product change and one for a new product, and updated the quality system for QMSR.
Ongoing · Small device manufacturer
Continuity when quality leadership leaves
We’ve worked with several companies that lost their quality lead just weeks before an ISO 13485 audit. In every case, the company earned or kept its certification. In one example, a contract manufacturer also had an internal audit and two supplier audits due in the same six weeks, along with a backlog of complaints, nonconformances, supplier evaluations, and overdue calibrations. We sorted the work by risk, ran tasks in parallel, and got the team started right away on work only they could do, such as updating the approved supplier list. All four audits were completed and the certification was maintained.
Weeks of notice · Certification kept
From idea to launch
We first met this founder when she had a goal and an idea, but no product or development plan yet. We gave her an overview of what to expect on the path to market. Two years later, she returned with startup investors, a contract firm developing the product, and a 510(k) ahead. For four years, Qualomics built the quality system from scratch, including bringing manufacturing in house, and supported the 510(k) submission. The company graduated from Qualomics and grew to the point of hiring its own full-time quality manager.
Six years · Founder to full-time QA hire