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 that partners with medical device manufacturers to navigate complex FDA requirements and achieve market access. They emphasize a hands-on approach to problem-solving.
**Expertise & scope**
* FDA 510(k) compliance consulting
* Medical device recall management, including notification, documentation, and FDA communication
* Quality audit services, identifying compliance gaps and process improvement opportunities
* FDA 483 observation response and remediation support
* Quality Management System (QMS) development and implementation, including PDF-based systems
* Support for various regulatory standards such as 21 CFR 820, MDSAP, ISO 13485, CMDR, and EU MDR
**Reputation / proof points**
* 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.
* Over 20 years of practical industry experience in quality audits.
* Experience developing and defending quality systems for companies of all sizes, from Fortune 100 to startups.
* PDF-based QMS reviewed by FDA inspectors and EU Notified Bodies.
Vision28 is a regulatory consulting firm that partners with medical device manufacturers to navigate complex FDA requirements and achieve market access. They emphasize a hands-on approach to problem-solving.
**Expertise & scope**
* FDA 510(k) compliance consulting
* Medical device recall management, including notification, documentation, and FDA communication
* Quality audit services, identifying compliance gaps and process improvement opportunities
* FDA 483 observation response and remediation support
* Quality Management System (QMS) development and implementation, including PDF-based systems
* Support for various regulatory standards such as 21 CFR 820, MDSAP, ISO 13485, CMDR, and EU MDR
**Reputation / proof points**
* 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.
* Over 20 years of practical industry experience in quality audits.
* Experience developing and defending quality systems for companies of all sizes, from Fortune 100 to startups.
* PDF-based QMS reviewed by FDA inspectors and EU Notified Bodies.
Additional information
Vision28 offers comprehensive support for medical device recalls, guiding clients through the entire process from initial notification to FDA closure. This includes developing recall strategies, writing compliant recall letters, and performing required effectiveness checks. They also provide assistance with responding to FDA 483 observations and warning letters, including conducting mock inspections to verify remediation efforts. Their quality management systems are designed to be audit-ready and can be customized to integrate existing company procedures, with implementation typically taking two to four weeks.
Key Highlights
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Offers comprehensive FDA 510(k) compliance consulting services.
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“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.
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“We will help you properly notify the FDA, distributors, and customers of a recall.”
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Specializes in responding to FDA 483 observations and warning letters.
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“Need Help Responding to an FDA 483?”
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Develops and implements PDF-based Quality Management Systems reviewed by FDA and EU Notified Bodies.
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“PDF-based Quality Management System that has been reviewed in detail by FDA inspectors...”
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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.”
Certifications & Trust Signals
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Over 20 years of practical industry experience in quality audits.
Source
“20+ years of practical industry experience.”
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Experience developing and defending quality systems for companies ranging from Fortune 100 to startups.
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“Vision28 professionals have experience developing and defending quality systems in companies ranging in size from worldwide Fortune 100 companies to start-ups...”
Buyer Snapshot
Best for
- Medical device manufacturers seeking FDA compliance support.
- Companies needing assistance with 510(k) submissions.
- Businesses requiring help managing product recalls or responding to FDA observations.
How engagement typically works
- Hands-on problem-solving.
- Partnership approach to regulatory challenges.
- Customized service delivery.
Typical deliverables
- FDA 510(k) submission strategy and documentation.
- Recall management plans and execution.
- Quality audit reports and recommendations.
- FDA 483 response strategies.
- Implemented Quality Management Systems.
Good to know
- Best when clients require expert guidance on complex FDA regulations.
- Ideal for companies needing to establish or improve their quality systems.
HQ:
Salem, US
Languages:
English
Timezones:
America/Los_Angeles
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, FDA 483 response, quality audits, Quality Management System development.
Pathways Supported
510(k)
