Medical Device Consulting Services

                  

 


Contents

About the Company

About the Consultant

Services Provided and Examples

Quality Statement

Regulatory Knowledge Base

Quality Values

Contact Information

Favorite Links

 

About the Company

SRS provides a range of assistance in the fields of regulatory compliance and regulatory affairs for the medical device industry. Our goal is to help companies maintain their competitive edge through cost effective compliance and product registration strategies.

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About the Consultant

Gus Kobrin has over 25 years of  experience in the medical device manufacturing industry. Regulatory Affairs and Regulatory Compliance experience built upon a foundation of engineering testing. Mr. Kobrin has diverse, hands-on experience with international and domestic product registrations of all medical device classifications; regulatory inspections; quality system development; auditing, and project management. Gus Kobrin is a Certified Quality Auditor (CQA) and Certified Regulatory Affairs professional (RAC). Gus Kobrin is bi-lingual, Spanish-English. 

 

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Services Provided and Examples

* Domestic and international filing strategies and submissions- USA, Canada, and European Community

* Product Development Support

* Domestic and international facility registrations

* Regulatory inspection management

* Product recall management

* Internal, Supplier and Clinical Audits

* Quality system development

* Litigation Support

* QMS Training

* QMS Training

 

 

 

 

 

 

 

 

 

Examples

Situation

Action

Results

Regulatory: inspection preparation, counseling, and responses.

Multi- inspector FDA inspection.

*        Developed procedure

*        Trained personnel

*        Identified responsible individuals

*        Coordinated activities

*        Coordinated inspection

*        Developed responses and action items

Good compliance profile for the company. Re-inspection produced no additional observations.

Quality system procedure design.

Multi-national product complaint handling system not in compliance with regulations and roles not well defined.

*        Developed and implemented a new complaint handling process and procedure.

*        Established complaint trending method.

System passed FDA and notified body inspections.

Quality Systems Development and training

Change control system was inadequate to support a good decision making process.

*        Identified weakness in the process.

*        Contributed to re-design. Conducted multidisciplinary training sessions for the new process.

Improved justification for changes and documentation of changes.

CE marking

CE marking of products.

*        Trained engineers to develop technical file.

*        Prepared and submitted technical dossiers.

Received timely approvals.

FDA product registrations

Modifications to product required PMA supplements; 510(k)s; IDE

*        Developed strategy to ensure appropriate data was available to expedite FDA approval.

*        Wrote and submitted filings.

Received timely approvals.

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Regulatory Knowledge Base (examples)

 

FDA:

21CFRParts: 7, 11, 50, 56, 58, 801, 803, 806, 807, 810, 812, 814, 820, 821.

Europe/International:

MDD Directive, CMDR, ISO: 9000, ISO 13485, ISO 10993, ISO 14971, EN 980, EN 556

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Quality Statement

SRS will conduct its work to ensure medical device specification developers and manufacturers achieve their goals in a manner compliant with applicable regulations. SRS shall provide cost effective and timely regulatory advice.

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Quality Values

Clients

Our primary mission is helping our clients achieve their goals through cost effective compliance and product registration strategies.

Knowledge

Good decisions are based upon sound knowledge. We invest in education to offer our clients advice based upon current and accurate information.

Ethics

Our business is conducted in an ethical manner. We provide services to companies that share this philosophy.

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Contact Information

Company

Strategic Regulatory Solutions

Address

8502 E. Chapman Ave., PMB 234

Orange, CA 92869

Telephone:

(714) 508-8048

FAX:

(714) 508-8048

e-mail:

srsolut@aol.com

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Favorite Links

* American Society for Quality

* Advanced Medical Technology Association (AdvaMed)

* EUROPA- European Commission-Enterprise

* Federal Register

* Food and Drug Administration (FDA-CDRH)

* Food and Drug Law Institute (FDLI)  

*Health Canada- Therapeutic Products Directorate

* Medical Device Link

* Orange County Regulatory Affairs Discussion Group (OCRA)

* Regulatory Affairs Professionals Society (RAPS)

* US Code of Federal Regulations

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Last Revised: 25 March 2005