Vision28
If your device is intended to diagnosis a disease or other health conditions, or if your device is involved in the cure, mitigation, treatment, or prevention of disease, or if your device is intended to affect the structure or any function of the body, then...
510k submission services: If your device is intended to diagnosis a disease or other health conditions, or if your device is involved in the cure, mitigation, treatment, or prevention of disease, or if your device is intended to affect the structure or any function of the body, then your device is a medical device per Section 201(h) of the Food, Drug, and Cosmetic Act.
By this definition, a toothbrush is a medical device because it is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.
You can check to see if your device is a medical device by searching FDA’s product classification database. A manual toothbrush has a product code of EFW.
About
**Who they are**
Vision28 is a regulatory consulting firm specializing in medical device compliance. They focus on helping manufacturers navigate complex FDA regulations to achieve market access and maintain compliance.
**Expertise & scope**
* FDA 510(k) compliance consulting
* Medical device recall management and FDA communications
* Quality audit services, including MDSAP, ISO 13485, and EU MDR compliance
* FDA 483 observation response and remediation support
* Quality Management System (QMS) development and implementation, including PDF-based systems
* Support for various regulatory pathways and standards such as 21 CFR 820, MDSAP, ISO 13485, CMDR, and EU-MDR
**Reputation / proof points**
* Possess over 20 years of practical industry experience in medical device regulations.
* Auditor certifications include ASQ Certified Quality Auditor (CQA), MDSAP, IVDR, ISO 9001, ISO 17025, Certified EU MDR 2017/645 Auditor, and ISO 13485:2016 Auditor.
* Experience developing and defending quality systems for companies ranging from Fortune 100 to startups.
* Have helped customers attain EU MDR, ISO 13485:2016, and MDSAP certification.
* Assisted customers in succeeding with 21 CFR 820 FDA audits.
Vision28 is a regulatory consulting firm specializing in medical device compliance. They focus on helping manufacturers navigate complex FDA regulations to achieve market access and maintain compliance.
**Expertise & scope**
* FDA 510(k) compliance consulting
* Medical device recall management and FDA communications
* Quality audit services, including MDSAP, ISO 13485, and EU MDR compliance
* FDA 483 observation response and remediation support
* Quality Management System (QMS) development and implementation, including PDF-based systems
* Support for various regulatory pathways and standards such as 21 CFR 820, MDSAP, ISO 13485, CMDR, and EU-MDR
**Reputation / proof points**
* Possess over 20 years of practical industry experience in medical device regulations.
* Auditor certifications include ASQ Certified Quality Auditor (CQA), MDSAP, IVDR, ISO 9001, ISO 17025, Certified EU MDR 2017/645 Auditor, and ISO 13485:2016 Auditor.
* Experience developing and defending quality systems for companies ranging from Fortune 100 to startups.
* Have helped customers attain EU MDR, ISO 13485:2016, and MDSAP certification.
* Assisted customers in succeeding with 21 CFR 820 FDA audits.
Additional information
Vision28 emphasizes a hands-on approach, stating they "roll up their sleeves and solve problems" rather than just consult. They offer tailored solutions, customizing Quality Management Systems to integrate existing work instructions and procedures. Their QMS development can include creating Design History Files, Device History Records, Device Master Records, performing validations, and conducting risk analysis. They aim for rapid implementation, with systems potentially up and running in two to four weeks, supported by ongoing training and scalable solutions.
Key Highlights
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Offers comprehensive FDA 510(k) compliance consulting services.
Source
“Unlock the Path to Market: Simplify Your 510(k) FDA Clearance Solutions”
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Provides expert assistance with medical device recalls, including notification, documentation, and FDA communication.
Source
“We will help you properly notify the FDA, distributors, and customers of a recall.”
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Conducts quality audits and offers support for responding to FDA 483 observations and warning letters.
Source
“Need Help Responding to an FDA 483?”
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Develops and implements customized PDF-based Quality Management Systems.
Source
“PDF-based Quality Management System that has been reviewed in detail by FDA inspectors”
Certifications & Trust Signals
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Auditor certifications include ASQ CQA, MDSAP, IVDR, ISO 9001, ISO 17025, EU MDR 2017/645, and ISO 13485:2016.
Source
“Our auditor certifications include ASQ Certified Quality Auditor (CQA), MDSAP, IVDR, ISO 9001, ISO 17025, Certified EU MDR 2017/645 Auditor, and ISO 13485:2016 Auditor.”
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Possesses over 20 years of practical industry experience.
Source
“20+ years of practical industry experience.”
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Has helped customers achieve EU MDR, ISO 13485:2016, and MDSAP certification.
Source
“Vision28 has helped customers attain EU MDR, ISO 13485:2016, and MDSAP certification”
Buyer Snapshot
Best for
- Medical device manufacturers seeking FDA 510(k) clearance.
- Companies needing assistance with FDA recalls and corrections.
- Organizations requiring QMS development or audit readiness.
How engagement typically works
- Hands-on problem-solving.
- Customized service delivery.
- Direct regulatory support.
Typical deliverables
- FDA 510(k) submission strategy and documentation.
- Recall notification and documentation support.
- Quality audit reports and remediation plans.
- Customized Quality Management Systems.
- FDA 483 response documentation.
Good to know
- Best when requiring expert guidance on FDA regulations and quality systems.
- Ideal for companies needing to address specific compliance gaps or prepare for audits.
HQ:
Salem, US
Languages:
English
Timezones:
America/Los_Angeles
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Services Offered:
510(k) Strategy & Authoring, Predicate Research & Substantial Equivalence Strategy, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
Medical device
Supports Estar:
No
Supports Rta Remediation:
No
Supports Predicate Research:
Yes
Supports Labeling Review:
No
Provides Submission Project Management:
Yes
Years Experience:
20
Ex FDA:
Yes
Ex Notified Body:
Yes
Ex Big Medtech:
Yes
Engagement Models:
Consulting
Accepting New Clients:
Yes
Typical Lead Time Weeks:
4
Response Time Hours:
24
Additional 510k_submission_services Details
Services Offered
510(k) strategy and authoring, 510(k) clearance solutions, FDA recall consulting, quality audits, FDA 483 response, warning letter response, Quality Management System development.
Pathways Supported
510(k), 21 CFR 820, MDSAP, ISO 13485, CMDR, EU-MDR.
