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 FDA compliance for medical device manufacturers. They focus on helping companies navigate complex regulatory pathways and maintain quality systems.
**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 and Warning Letter response assistance
* Quality Management System (QMS) development and implementation, including PDF-based systems and support for ISO 13485 and MDSAP certifications
* Assistance with Design History Files, Device History Records, Device Master Records, validations, and risk analysis
**Reputation / proof points**
* Professionals have experience developing and defending quality systems in companies ranging from Fortune 100 to start-ups.
* Experience with FDA audits, EU Notified Bodies, and certifications like EU MDR, ISO 13485:2016, and MDSAP.
Vision28 is a regulatory consulting firm specializing in FDA compliance for medical device manufacturers. They focus on helping companies navigate complex regulatory pathways and maintain quality systems.
**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 and Warning Letter response assistance
* Quality Management System (QMS) development and implementation, including PDF-based systems and support for ISO 13485 and MDSAP certifications
* Assistance with Design History Files, Device History Records, Device Master Records, validations, and risk analysis
**Reputation / proof points**
* Professionals have experience developing and defending quality systems in companies ranging from Fortune 100 to start-ups.
* Experience with FDA audits, EU Notified Bodies, and certifications like EU MDR, ISO 13485:2016, and MDSAP.
Additional information
Vision28 emphasizes a hands-on approach, aiming to integrate seamlessly with a client's existing processes. They offer customized Quality Management Systems designed to be audit-ready and can be implemented quickly, often within two to four weeks. Their services extend to training and ongoing support, ensuring scalability as a company grows. They also provide mock audits to prepare teams for regulatory inspections and can assist in responding to FDA 483 observations and warning letters, including mock inspections post-remediation.
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.
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“We will help you properly notify the FDA, distributors, and customers of a recall.”
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Specializes in Quality Management System development, supporting ISO 13485, MDSAP, and EU MDR.
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“Vision28 has helped customers attain EU MDR, ISO 13485:2016, and MDSAP certification”
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Assists clients in responding to FDA 483 observations and Warning Letters.
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“Need Help Responding to an FDA 483?”
Certifications & Trust Signals
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Professionals possess extensive practical industry experience.
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“20+ years of practical industry experience.”
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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.
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.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking FDA 510(k) submission assistance.
- Companies needing to establish or improve their Quality Management System.
- Firms requiring support with FDA inspections, recalls, or regulatory responses.
How engagement typically works
- Hands-on problem-solving.
- Customized service delivery.
- Direct support and training.
Typical deliverables
- FDA 510(k) submission documentation.
- Implemented Quality Management System (QMS).
- Recall strategy and execution plans.
- Responses to FDA 483s and Warning Letters.
- Audit reports and remediation guidance.
Good to know
- Best when clients are prepared to actively participate in the compliance process.
- Ideal for companies needing to address specific FDA regulatory challenges or build robust quality systems.
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) submission strategy and authoring, Quality System development (21 CFR 820, ISO 13485, MDSAP), Medical Device Recall management, FDA 483 response, Warning Letter response, Quality Audits, Predicate research, Health Hazard Evaluation, Recall Strategy development, Recall Letter writing, Recall closure.
Pathways Supported
Traditional 510(k), Special 510(k), Abbreviated 510(k).
Supports Estar
No explicit mention of eSTAR support.
Supports Rta Remediation
No explicit mention of RTA remediation.
Supports Predicate Research
Yes, mentioned in the context of 510(k) submissions.
Supports Labeling Review
No explicit mention of labeling review.
Provides Submission Project Management
Implied through comprehensive 510(k) consulting services.
