Consultation Services

SafeLink Consulting specializes in assisting businesses develop solid programs for Health and Safety, Quality Management, and Lean Manufacturing. We can provide onsite or phone consultations to best suit your needs. SafeLink Consulting can help you in your response should your facility be visited by OSHA or FDA. Contact us for a quote on any of these services.

Onsite Health and Safety Program
Complying with OSHA Regulations

Need assistance in developing your Health & Safety Program, training your employees, or just need an objective outsider’s viewpoint of your existing Program? SafeLink Consulting can provide guidance with compliance of OSHA’s federal and state government regulations and assist you in ensuring a healthy and safe workplace for your employees. We customize your Health & Safety Manual to meet your business needs, as well as, train your safety coordinator and all of your employees on proper health and safety procedures. We can also conduct an onsite survey of your facility to measure the effectiveness of your current safety program. Let SafeLink Consulting be your source of knowledge. See what our clients have to say about our health and safety services.
What Our Health and Safety Program Will Do For You

• Educate you and your staff in proper job safety procedures through fun, interactive programs.
• Increase employee morale and productivity by supporting an employer "we care" philosophy.
• Reduce lost man hours due to work-related injuries and illnesses.
• Provide continuing education credits for exposure control, hazard communication, and emergency training.
• Save you time from having to tediously research and understand the complicated OSHA, DOT, and CDC guidelines. We do it for you.
• Save you money by contracting us at a fraction of the cost of hiring additional in-house staff to assist you with your health and safety program.
• Assist you with response to OSHA if you receive an inquiry.
• Help you to minimize citations/fines in the event you are inspected by OSHA.
• Provide credibility as a change agent for safety in your organization.

Quality Connection (QC) System / DAMAS Consultation
Meeting FDA Requirements

Need assistance in developing your business Quality Management Program, or need DAMAS third party certification, or need an external audit conducted as required by DAMAS or FDA? SafeLink Consulting provides guidance in not only complying with the FDA requirements, but also helping you to infuse a “quality attitude” throughout your organization. SafeLink Consulting’s Quality Connection (QC) Program addresses the issues specific to your business regardless of size. Either through our onsite visits or workshops, we will teach you how to ensure all required quality management system elements are identified, scaled appropriately to meet compliance requirements, and effectively implemented. We provide a two-day onsite visit, a written customized Quality Manual, Standard Operating Procedures Manual, flow charts, forms, calls, and email assistance plus follow up. Should you hear from an FDA inspector, we’ll provide guidance. See what our clients have to say about our quality management services.

What Our Quality Assurance Program Will Do For You

1. Educate you and your management team in on implementation and development of a quality assurance system.

• Provide roll-out meetings to employees to introduce the quality assurance system.
• Provide continuing education credits for Regulatory Standards.
• Save you time from having to tediously research and understand the complicated FDA Quality System Regulations. We do it for you.
• Save you money by contracting us at a fraction of the cost of hiring additional in-house staff to assist you with your quality assurance program.
• Assist you with response to FDA if you receive an inspection.
• Help you to minimize citations/fines in the event you are inspected by FDA.

Are You Ready For The FDA or for a DAMAS third-party audit?

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

Contact us for a quote on any of these services.

The Lean Quality Advantage