Life Science Solutions | Kymanox | Life Science Solutions Partner

Additional Life Science Services

Kymanox gives you peace of mind by providing technical experience to make your product a success

Development & Operations

• Product & Process Development

• CMC Services & Analytical Sciences

• Process Engineering

• MS&T and Supply Chain

• Human Factors Regulatory & Strategy (HURAS)

• Packaging Technology & Engineering

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Quality, Regulatory, & Compliance

• Quality Assurance, Compliance & Auditing

• Quality Engineering

• Quality Control

• Regulatory Affairs

• Clinical & Medical Affairs

• CGxP Microbiology & Environmental Monitoring

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Commissioning, Qualification, & Validation

• Validation Master Planning

• Facilities & Utilities CQV

• Lab & Plant Equipment CQV

• Computer System Validation (CSV)

• Process Validation

• Cleaning Validation

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Strategy, Planning, & Execution

• Program & Project Management

• Technology Transfer

• Innovation Solutions

• Enterprise Resource Planning & Solutions

• Due Diligence

• Staffing Solutions

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Life Science Products & Services Where We Excel

Medical Devices

Medical Devices

Tissue & Organ

Tissue & Organ

Contract Development & Manufacturing Organizations (CDMO)

CDMO

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Helpful links on this topic

Here are some of our favorite resources on this topic

FDA: Classify Your Medical Device

Guidance from FDA on how to identify if your medical device is Class I, II, or III

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How to Determine if Your Product is a Medical Device

The official FDA perspective on determining the official status of your device

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Frequently Asked Life Science Questions (FAQs)

What’s the difference between Class I, II, and III medical devices?

As described by the FDA, federal law established the risk-based device classification system for medical devices. Each device is assigned to one of three regulatory classes: Class I, Class II or Class III, based on the level of control necessary to provide reasonable assurance of its safety and effectiveness. As device class increases from Class I, to Class II to Class III, the regulatory controls also increase, with Class I devices subject to the least regulatory control, and Class III devices subject to the most stringent regulatory control. The regulatory controls for each device class include:

Class I (low to moderate risk): general controls

Examples include bandages, handheld surgical instruments, oxygen masks, electric toothbrushes, and unpowered wheelchairs.

Class II (moderate to high risk): general controls and Special Controls

Examples include syringes, contact lenses, blood pressure cuffs, powered wheelchairs and some pregnancy test kits.

Class III (high risk): general controls and Premarket Approval (PMA)

Examples include pacemakers, breast implants, defibrillators, cochlear implants, and implanted prosthetics.

Can I just outsource this work to Kymanox?

In short, yes. Kymanox has a flexible approach with our clients that is based on the unique needs of that particular situation. In some situations we basically act as employees of our clients, effectively acting as a functional department within their company. You can’t tell a Kymanox employee apart from our clients in these situations. We have additional options to meet your needs as well. One advantage to the Kymanox approach is that we empower our team of full-time employees and contractors, with access to our entire team of experts so when you hire Kymanox you get the benefit of our collective experience. We invite you to learn more about our Staffing Solutions.

I have a pretty big project. Can Kymanox handle it?

Kymanox has extensive experience on multi-million dollar projects at some of the largest pharmaceutical, biologics, and medical device companies in the world. Our processes were built with the ability to scale to meet the needs of a virtual biotech startup, the largest of big pharma, and everything in between. One key to our success is our Program & Project Management team, our secret weapon in making sure we stay on track with our agreed upon scope and keeping clients informed so they can rest easy knowing there will be no surprises. Our approach is flexible so you’ll get just the right amount of project management for your needs.