Medical Device Manufacturers

Introducing SafeLink360: One Platform, Real Expertise

Today, we’re officially launching SafeLink360, a compliance management platform that gives organizations a structured way to manage regulatory requirements from assessment through

QSR vs. QMSR: What Changed & What It Means for Device Manufacturers

QSR vs. QMSR: What Changed and What It Means for Manufacturers For three decades, FDA investigators evaluated device manufacturers against a single, homegrown rulebook: 21 CFR Part

SafeLink's Gary Morgan Returns to NADL University to Teach Quality Assurance & GMP

SafeLink Consulting is proud to share that Gary Morgan, CDT, CQA/ASQ our Senior Vice President & Partner, will once again be leading a core session at NADL University this Septembe

Beyond Decibels: How Workplace Chemicals Contribute to Hearing Loss

Hearing loss in the workplace isn't always caused by noise. A category of chemicals known as ototoxicants can also damage hearing, often without employees realizing they're at risk

OSHA Hazard Communication Update: Has Your Workplace Kept Pace?

The first major compliance deadline under OSHA's revised Hazard Communication Standard has arrived. These hazard communication changes have the potential to impact your business.

Fireworks Safety at Company Events: Risks Employers Should Know

For employer-sponsored events, fireworks safety is not just a holiday concern. It is a fire prevention, hazard control, and potential OSHA recordkeeping issue. Every summer, firewo

Celebrate National Safety Month in June

Since 1996, the National Safety Council has recognized June as National Safety Month. This is a time to raise awareness and promote safe practices in all environments. At SafeLink,

How to Develop a Lockout/Tagout Program

No matter the level of industry hazard, all general industry businesses must implement elements of Lockout Tagout if they apply to their business according to the OSHA Standards. {

Elements of an Effective Electrical Safety Policy

Many businesses are not aware that OSHA requires a written Lockout/Tagout Program for electrical safety, which is why the absence of this program continues to be one of the OSHA mo

SafeLink Appoints Matt Rahman as President & Managing Partner

We are proud to announce the appointment of Matt Rahman as President & Managing Partner of SafeLink Consulting. This strategic move reflects where this firm is headed and what our

SafeLink Presents at FDLA's Southern States Symposium

Join SafeLink’s Gary Morgan, CDT, CQA/ASQ, at the FDLA Southern States Symposium & Expo on June 6, 2026, for two focused regulatory courses. The first course examines the regulator

Ortho Labs Be Aware - FDA is Watching!

Take note ortho labs - FDA is watching what you are marketing. Recently some labs, specifically orthodontic labs, have received letters from FDA inquiring about the marketing of ce

OSHA Releases Updated Job Safety & Health Workplace Poster: What Employers Need to Know

The Occupational Safety and Health Administration (OSHA) has released an updated Job Safety and Health Workplace Poster as part of its “OSHA Cares” initiative. The poster reminds w

The Risk & Compliance Paradox: Why Dental & Healthcare Organizations Are Overtrained Yet Under-Supported

In the complex world of healthcare risk & compliance management, a troubling pattern has emerged across dental labs, dental practices, medical offices, and small health and wellnes

Top 10 OSHA Most Frequently Cited Safety Violations FY2025

Every year, the Occupational Safety and Health Administration (OSHA) releases its list of the most frequently cited workplace safety violations, highlighting critical areas where e

Year-End Reflections: Health & Safety for General Industry

As the year comes to a close, many organizations reflect on performance, challenges, and opportunities for improvement. Alongside financial and operational results, workplace healt

Take-Home Exposures on Street Clothes

OSHA requires employers to assess workplace hazards and determine how to eliminate or minimize them. Within the hierarchy of controls, personal protective equipment (PPE) is consid

Identifying and Assessing Hazards in the Workplace

After recently presenting a course on hazard identification and assessment, it struck me how many employers could benefit from revisiting this essential process. According to OSHA,

Benefits of a Document Control System in a QMS

The paperwork generated by a Quality Management System (QMS) can be overwhelming unless you implement a structure that is simple and user-friendly. The data can be retained in auto

Listening to the Voice of the Customer (VOC)

In today’s competitive business environment, having effective methods in place to capture the Voice of the Customer (VOC) is essential. Listening to your customers enables your bus

The Forgotten Member Of The Dental Team - The Dental Lab

Missed the Association for Dental Safety (ADS) live event? Access the on-demand course recording here - The Forgotten Member Of The Dental Team - The Dental Lab. This live webinar

How Would Your Management Controls Stand Up in an FDA Inspection?

One part, and usually the initial part, of an FDA inspection covers management controls. If you have a Quality Management System developed, then the documentation should be in plac

Work Smarter, Not Harder: Ergonomic and Safety Tips

If you’ve ever ended a long day with a sore back, stiff shoulders, or cramped fingers, you’re not alone. Whether you're at a desk, in a production environment, or working chairside

FDA Registration Renewal: 7 Steps for FY 2027

October 1 marks the start of the FDA's annual registration renewal period. Every medical device establishment that has to register must renew between October 1 and December 31 (21

Fire Prevention in the Workplace - How to Use Fire Extinguishers

Be an Asset Rather Than a Risk as a Supplier or Subcontractor

It is not unusual today for a medical device manufacturer to outsource components of their production to third party subcontractors or suppliers. The subcontractor or supplier is r

Enhance Trust in Your Supplier Management Process to Reduce Risk

Medical device manufacturers, including dental laboratories, must implement a supplier management process to comply with FDA's quality management system regulations. They must ensu

Top Ten Quality Mistakes - Part Two

Learning from mistakes, whether our own or others', is a valuable way to improve. In this article, I aim to highlight the top ten quality mistakes often made by businesses and prov

Top Ten Quality Mistakes - Part One

Since many of us seem to learn better from our own mistakes or the mistakes of others, I’d like to share with you some common top ten quality mistakes made by businesses and how yo

Delta Dental of California Faces Massive Data Breach

In a recent and alarming revelation, Delta Dental of California, a major player in the dental insurance sector, has fallen victim to a data breach affecting more than 6.9 million i

SafeLink Consulting & Grand Avenue Present eQMS Dental FDA Compliance

SafeLink Consulting is pleased to announce its new strategic relationship with Grand Avenue Software, a leading provider of electronic quality management systems, or eQMS tools for

Measuring Suitability and Effectiveness of your Quality System

As this year comes to a close and organizations move forward with their business planning for the new year, it’s important to remember that the Quality Management System (QMS) requ

6 Types of QMS Audits & Why Your Business Should Perform Them

What is a Quality Management System (QMS) Internal Audit and why is it so important? Understanding the purpose and accepting the value of a Quality Audit is vital for the effective

Why SOPs Are the Backbone of Healthcare Compliance

If your organization is regulated by the FDA, subject to HIPAA, or covered by OSHA workplace safety standards, Standard Operating Procedures (SOPs) aren't just good business practi

Gary Morgan, CDT, CQA/ASQ Receives NADL Merit Award

Congratulations to Gary Morgan, CDT, CQA/ASQ, on being presented the NADL Merit Award for Outstanding Achievements at the 2023 NADL Vision 21 Meeting in Las Vegas. Gary was present

OSHA's General Duty Clause Ups the Ante on Safety

The old idiom ignorance is bliss may be true in some circumstances, but not when it comes to ensuring the safety of your employees. Despite having strict safety policies in place a

National Preparedness Month - A Workplace Emergency Preparedness Guide

Every September, National Preparedness Month brings nationwide attention to a simple idea: prepare for emergencies before they happen. While hurricanes often receive the most atten

Tornado Preparedness In the Workplace

Severe weather season brings a heightened risk of tornadoes across much of the country, and many states designate a Severe Weather Preparedness Week each year — typically in late w

How to Create an Emergency Action Plan for Your Business: OSHA Guide

Updated: August 26, 2026 A fire alarm goes off. A chemical line ruptures. Severe weather rolls in with twenty minutes' notice. In the moment, your employees don't need a policy bin