OSHA Compliance

SafeLink offers risk management training services for general industry, including healthcare (dental and medical), industrials, manufacturing, telecommunications, and transportation.

SafeLink can assist you in ensuring a healthy and safe workplace for your employees. SafeLink provides guidelines for compliance with OSHA's federal and state government regulations. Our trainers are authorized under OSHA's Outreach Program.

The facility owners who have used our services have done so because of the costly time it takes to research the OSHA Standards and then conduct training with their employees. SafeLink can assist you at a fraction of what it would cost for you to develop a similar safety program on your own. We're here when you need us to assist you with decisions regarding employee safety issues including response to OSHA inspections. SafeLink can help you establish a plan that will reduce your workplace injuries which can ultimately reduce your overhead costs.

Typically, in one day, we conduct awareness sessions on job safety and cover the areas necessary to comply with the Standards. Our method of training increases employee morale and productivity by influencing a team effort attitude and employer "we care" philosophy. A direct result of proper safety training is reduction in lost man hours due to work-related injuries and illnesses.

The following is a summary of our services. These services save you valuable time and are cost-effective. Click on any service for more detail.

Complete Safety Training Program
Our authorized trainer under OSHA's Outreach Program provides onsite training to all of your employees, conducts an onsite safety survey of your facility, provides required written documentation, and trains your safety coordinator to maintain your program. One year of on-call consulting and updates due to governmental changes are provided.

On-Site Safety Survey
Measures the effectiveness of your safety program and provides an objective outsider's viewpoint regarding safety compliance.

On-Site Train-the-Trainer
Our authorized trainer provides onsite training to your in-house safety coordinator, provides required written documentation, and conducts an onsite safety survey of your facility. One-on-one training is conducted in your facility to simplify the tasks of training your employees and understanding OSHA guidelines. One year of on-call consulting and updates due to governmental changes are provided.

Workshops and Courses
Workshops are available to state associations, study clubs, etc. for presentation to their members. CE and NBC Documented Scientific Credits are provided. Honorarium Quoted.

Other Services

Contact a SafeLink Consultant for a quote on these valuable services.

FDA Compliance

Are You Ready For The FDA?
Domestic or foreign manufacturers of dental appliances are required by the Food and Drug Administration (FDA) to have "a quality system for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for commercial distribution in the United States." Refer to www.fda.gov , Title 21, Part 820 for the regulation in its entirety. The federal regulation, Title 21, Part 820 requires: that various specifications and controls be established for devices; that devices be designed under a quality system to meet these specifications; that devices be manufactured under a quality system; that finished devices meet these specifications; that devices be correctly installed, checked and serviced; that quality data be analyzed to identify and correct quality problems; and, that complaints be processed.

Specifically your Quality System should address the following:

• Determination of applicability and FDA registration (manufacture of Class II medical devices such as sleep apnea and snore guards requires registration; domestic labs outsourcing to offshore labs (and the offshore labs themselves) and labs that are re-packagers and re-labelers must register with FDA
• Assignment of management responsibility
• Defining of purchasing controls
• Identification/traceability of patient contact materials
• Production and process controls
• Acceptance of final product
• Review of Non-conforming product
• Corrective and Preventive Action procedures
• Control of Labeling and Packaging
• Handling, Storage, Distribution and Installation of materials and finished items
• Records retention and control system

QC On-site Program
SafeLink's most comprehensive Quality Management program is designed to provide additional guidance to the lab through, not only complying with the FDA requirements, but also helping the lab infuse a "quality attitude" throughout the organization in every aspect of its business.

External Quality Audit
DAMAS and FDA require periodic audits whether internally or externally conducted. A quality system audit is an independant unbiased fact-finding exercise that evaluates an existing quality program to determine its conformance to company policies, contract commitments, and regulatory requirements. It is strongly recommended that two to four weeks prior to a third party audit that this external audit be performed. The external audit results and corrective actions would typically be taken into consideration by the third party auditor in their decision for certification.

Third Party Certification through DAMAS or ISO Programs
SafeLink is your resource to assist you in achieving third party certification from either of these two recognizable programs. Our consultants will work with you through our oniste consultative services to help get your Quality System in tip-top shape for your certification process.