Regulatory Services Company, Inc.

Regulatory Services Company, Inc., provides consultation in medical device quality systems and regulatory requirements.  Our experience includes:

Successfully prepared numerous official submissions to FDA (and international authorities), including:

Premarket notifications (510(k))

Premarket approvals (PMAs)

Investigational device exemptions (IDEs)

Humanitarian device exemptions (HDEs)

Responses to FDA Warning Letters

Medical Device Reports (MDRs)

Designed and implemented quality systems compliant with 21 CFR 820 and ISO 13485:2003:

Corrective and Preventive Action (CAPA)

Complaint Evaluation and Response

Design Control

Management Responsibility

Process Validation

Purchasing Controls

Document Control

Designed and conducted numerous non-clinical studies for device safety in compliance with 21 CFR 58 and ISO 10993.

Designed and conducted pilot, feasibility and full-scale human investigations of device effectiveness.

Managed product recall, corrections, and notifications. 

Conducted multiple Due Diligence evaluations of potential business acquisitions.

Provided in-house training in QA and the Quality System Regulations to ensure all employees and agents are familiar with the Corporate QA Policy and expectations.

Provided training to sales representatives on product technical issues.

Whatever your RA/QA challenge as you develop your medical device business, Regulatory Services Company, Inc. can help.

2009 Don Selvey, All Rights Reserved. | Site Design by Spears Software