Us Operonstrategist
We are one of the leading medical device regulatory consultant in USA. We offer clients an array of services like turnkey services, system implementation, training, licensing, regu
510k submission services: We are one of the leading medical device regulatory consultant in USA. We offer clients an array of services like turnkey services, system implementation, training, licensing, regulatory approvals, and certifications.
Operon Strategist is a medical device consulting company in the USA that provides regulatory guidance to various manufacturers in the healthcare industry to ensure their strategic development. We serve our clients by providing turnkey services, system implementation, training, licensing, regulatory approvals, and certifications. We provide customized solutions to manufacturers looking to set up a world-class manufacturing unit.
Our global presence caters to clients from around the globe and includes everything from small start-ups to the world’s most renowned medical device manufacturers. We have a team of expert medical device consultants whose knowledge and experience help them handle clients both small and large.
About
**Who they are**
Us Operonstrategist is a medical device regulatory consultancy based in the USA, dedicated to assisting medical device manufacturers with regulatory guidance and advisory services to advance their product development.
**Expertise & scope**
* Specializes in helping medical device companies achieve full compliance with FDA 21 CFR Part 820 through expert consulting, ensuring Quality Management Systems (QMS) align with regulatory expectations.
* Provides end-to-end guidance for turnkey medical device projects, covering concept to commercialization, including planning compliant manufacturing facilities and meeting regulatory expectations.
* Assists in designing, implementing, and certifying QMS systems that meet FDA 21 CFR Part 820 and ISO 13485 standards.
* Offers consulting for ISO 13485 certification, including a step-by-step roadmap for establishing and implementing a compliant QMS.
* Provides support for ISO 15378 certification for medical device packaging, ensuring compliance with global quality and safety standards.
* Develops comprehensive Medical Device Product Feasibility Reports and Detailed Project Reports (DPRs) to validate concepts, ensure regulatory alignment, and support compliant manufacturing infrastructure.
**Reputation / proof points**
* Expertise in FDA 21 CFR Part 820 Quality System Regulation
* ISO 13485 Certification
* ISO 15378 Certification for Medical Device Packaging
* Medical Device Product Feasibility and Detail Project Report
* Turnkey Project Consultants
* Clean Room Guidance
* Validation Documentation
Us Operonstrategist is a medical device regulatory consultancy based in the USA, dedicated to assisting medical device manufacturers with regulatory guidance and advisory services to advance their product development.
**Expertise & scope**
* Specializes in helping medical device companies achieve full compliance with FDA 21 CFR Part 820 through expert consulting, ensuring Quality Management Systems (QMS) align with regulatory expectations.
* Provides end-to-end guidance for turnkey medical device projects, covering concept to commercialization, including planning compliant manufacturing facilities and meeting regulatory expectations.
* Assists in designing, implementing, and certifying QMS systems that meet FDA 21 CFR Part 820 and ISO 13485 standards.
* Offers consulting for ISO 13485 certification, including a step-by-step roadmap for establishing and implementing a compliant QMS.
* Provides support for ISO 15378 certification for medical device packaging, ensuring compliance with global quality and safety standards.
* Develops comprehensive Medical Device Product Feasibility Reports and Detailed Project Reports (DPRs) to validate concepts, ensure regulatory alignment, and support compliant manufacturing infrastructure.
**Reputation / proof points**
* Expertise in FDA 21 CFR Part 820 Quality System Regulation
* ISO 13485 Certification
* ISO 15378 Certification for Medical Device Packaging
* Medical Device Product Feasibility and Detail Project Report
* Turnkey Project Consultants
* Clean Room Guidance
* Validation Documentation
Additional information
Us Operonstrategist focuses on providing comprehensive support for medical device manufacturers navigating complex regulatory landscapes. Their services are designed to streamline the path to market by ensuring compliance with key standards such as FDA 21 CFR Part 820 and ISO 13485. They offer practical assistance in areas like QMS implementation, manufacturing facility planning, and product feasibility studies. Engagement typically involves close collaboration to address specific project needs, from initial concept validation through to post-market responsibilities. Buyers can expect detailed reports and strategic guidance tailored to U.S. market entry and global compliance.
Key Highlights
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Specializes in FDA 21 CFR Part 820 Quality System Regulation consulting for US market entry.
Source
“At Operon Strategist, we specialize in helping medical device companies achieve full compliance with FDA 21 CFR Part 820 through expert consulting...”
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Offers end-to-end guidance for turnkey medical device projects, from concept to commercialization.
Source
“As a Medical Device Turnkey Project Consultant in the USA, we provide end-to-end guidance to help you complete every stage of your project efficiently.”
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Assists in designing, implementing, and certifying Quality Management Systems (QMS) for FDA 21 CFR Part 820 and ISO 13485 compliance.
Source
“At Operon Strategist, we help medical device manufacturers design, implement, and certify QMS systems that fully meet FDA 21 CFR Part 820 and ISO 13485 standards.”
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Provides comprehensive Medical Device Product Feasibility Reports and Detailed Project Reports (DPRs).
Source
“Operon Strategist provides comprehensive Medical Device Product Feasibility Reports and Detailed Project Reports (DPRs) for startups and manufacturers across the United States.”
Certifications & Trust Signals
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Expertise in ISO 13485 Certification for medical devices in the USA.
Source
“Looking to achieve ISO 13485 certification in the USA? Operon Strategist helps medical device manufacturers, startups, and exporters establish and implement a compliant Quality Management System (QMS)...”
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Provides support for ISO 15378 certification for medical device packaging.
Source
“Operon Strategist provides end-to-end support for ISO 15378 certification tailored to startups operating in the United States medical device industry.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking regulatory compliance in the USA.
- Companies needing assistance with QMS implementation and certification (FDA 21 CFR Part 820, ISO 13485).
- Startups requiring feasibility studies and project reports for new medical devices.
- Businesses looking for end-to-end support for turnkey medical device projects.
How engagement typically works
- Collaborative consulting and advisory services.
- End-to-end project management for turnkey solutions.
- Development of tailored QMS and project documentation.
- Guidance on regulatory requirements and standards.
Typical deliverables
- FDA 21 CFR Part 820 compliance strategies.
- ISO 13485 certification support.
- Medical Device Product Feasibility Reports.
- Detailed Project Reports (DPRs).
- Turnkey project execution plans.
- Manufacturing facility and clean room guidance.
Good to know
- Best when engaging for US market entry and compliance.
- Requires clear project scope for turnkey solutions.
- Ideal for manufacturers needing structured regulatory and quality system support.
HQ:
USA
Languages:
English
Status:
listed
Services & Capabilities
FDA 510(k) Submission Services
Services Offered:
510(k) Strategy & Authoring, Predicate Research & Substantial Equivalence Strategy, Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k)
Device Types Supported:
Medical device, Combination product
Supports Estar:
No
Supports Rta Remediation:
No
Supports Predicate Research:
Yes
Supports Labeling Review:
No
Provides Submission Project Management:
Yes
Engagement Models:
Turnkey Project Consultants
Additional 510k_submission_services Details
Services Offered
Turnkey project consulting, QMS design and implementation, ISO 13485 certification consulting, FDA 21 CFR Part 820 consulting, ISO 15378 certification consulting, Medical Device Product Feasibility Reports, Detailed Project Reports (DPRs), Validation Documentation, Manufacturing Facility guidance, Clean Room guidance.
Pathways Supported
The provided content does not explicitly detail specific 510(k) pathways supported (e.g., Traditional, Special, Abbreviated), nor does it mention De Novo, PMA, or Pre-Sub/Q-Sub submissions. It focuses on regulatory compliance and QMS.
Supports Estar
Not explicitly mentioned.
Supports Rta Remediation
Not explicitly mentioned.
Supports Predicate Research
Not explicitly mentioned.
Supports Labeling Review
Not explicitly mentioned.
Provides Submission Project Management
Implied through turnkey project consulting and overall regulatory guidance, but not explicitly stated as a distinct service for 510(k) submissions.
