U. S. and Canadian medical device requirements for dental laboratories are not the same. Whether your dental lab is considering doing business or already doing business in Canada you need to know this information.
Does outsourcing lab work to Canada have any FDA implications? Watch this video to find out what a dental laboratory needs to know when doing business in Canada. Whether a U.S. dental lab or other foreign lab your business must meet these requirements when doing business in Canada.
Need assistance with determining your lab's needs when doing business in Canada or assistance with registration? Contact SafeLink Consulting.
What can SafeLink Consulting do for my business?
We address your business needs whether they are a basic quality system to meet FDA compliance or an expanded quality system to improve good business practices. We provide customized programs specific to your business model. SafeLink Consulting offers your business the whole package on quality systems, safety programs, patient security and chairside services plus compliance with FDA, OSHA & HIPAA. For over 25 years SafeLink has been helping the dental industry with compliance. Our staff, including CDT’s and former lab owners, has over 100 years of combined experience in the dental environment. SafeLink also has Authorized OSHA Outreach Trainers on staff, DAMAS certification auditors, and third-party quality auditors on staff who are ASQ certified. Our clients also benefit from our broad experience with Quality System development for other medical device manufacturers. We also offer risk assessments, cloud-based data management programs, ISO registration and FDA 510k submission assistance. We are one of the premier FDA consulting firms in the dental industry assisting labs with medical device US import requirements. Our FDA compliance consultants are knowledgeable of the dental environment. Learn more about specific quality/FDA topics by taking any of our educational, online courses available 24/7 when it’s convenient for you.
Are you a manufacturer of dental devices? Need Quality System consulting or other dental compliance services?
Here's what SafeLink Consulting can do for you:
Learn more about what SafeLink Consulting can do to help your business with compliance services, including safety compliance, to meet OSHA training requirements and quality system consulting to meet FDA compliance. SafeLink Consulting assists businesses with workplace safety training, infection control training, HIPAA training online, quality systems, assessments, audits, due diligence, and more.
Industries include:
Dentistry compliance - assisting the dental practice with meeting requirements for OSHA, HIPAA, EPA, and CDC guidelines, patient safety and employee health & safety
Dental Laboratory compliance - assisting the dental lab with meeting requirements for OSHA, FDA, and CDC guidelines, employee health & safety, plus FDA requirements for lab manufacturing custom implant abutment /gmp for medical device manufacturers
Medical Device Manufacturers compliance - assisting with meeting OSHA compliance & FDA requirements, GMP - good manufacturing practices
General Industry compliance - assisting with OSHA compliance and FDA compliance as it pertains to the specific business
Beverage Industry compliance - assisting beverage businesses such as the craft brewery, winery, cidery, distillery, vintner with meeting OSHA compliance, health & safety, FDA requirements / GMP - Good Manufacturing Practices.