Spectrum Killian Dental Lab Alliance

Spectrum Killian Dental Lab Alliance (SKDLA) is a cooperative network of full-service dental laboratories that have come together to provide high-quality products, dental implant solutions, and world-class esthetics.

Anika

Anika is a global joint preservation company that creates and delivers meaningful advancements in early intervention orthopedic care. We partner with clinicians to understand what they need most to treat their patients and we develop minimally invasive products that restore active living for people around the world. We are committed to leading in high opportunity spaces within orthopedics, including osteoarthritis pain management, regenerative solutions. Anika. Restore Active Living.® For more information about Anika, please visit: www.anika.com

Professional Hospital Furnishers

Welcome to Professional! We appreciate the time you have taken to check us out. Driven by a singular passion for perfecting medical instruments and a matching expertise to go with it, Professional hit the domain in 1972 as Metallic Products Corporation. We have come a long way ever since, from catering only to the US market as a surgical instruments partner to healthcare professionals in over 62 countries today on the planet. Over 40 years of our experience in the art and science of medical instruments-making, as you would expect, have only sharpened, deepened and broadened our efficiency in putting smart surgical instruments solutions in the dexterous hands of surgeons. It brings us immense joy that today responsible and successful medical professionals from around the world trust Professional for cost-effective surgical instruments of the highest order.

Helena Laboratories Corporation

Helena Laboratories is a clinical laboratory instrument and reagent manufacturer. Our clients include major medical centers, small hospitals, large reference laboratories and small private doctor's laboratories. Corporate headquarters, located in Beaumont, Texas (a major port city 80 miles east of Houston) is comprised of over a quarter million square feet of research, manufacturing, inventory, engineering and administrative facilities. Approximately 75 field specialists are located in major cities throughout the United States. Helena has been awarded the U.S. Secretary of Commerce "E"​ Award for excellence in contribution to the American economy through export operations. With hundreds of laboratory products and more than 40 registered patents, Helena continues to be a market leader in the development of new diagnostic tests.

Compliance Group Inc

Compliance Group is a Quality Compliance solutions provider based in Illinois, US with offices in NJ, the UK and India. Compliance Group’s motto is to provide “right-sized” compliance solutions. Compliance Group is the only service provider organization in FDA consortium. This FDA & Industry consortium is coming up with a paradigm shift in validation guidance for the industry. This knowledge & expertise has resulted in significant capital and operational savings for our clients. Compliance Group is also a Siemens Solution Partner in ALM space. With automation at the center of it's services, onsite/near-shore/offshore service delivery models, and presence in US/EU & India, Compliance Group has proven expertise supporting customers with the following: - Quality Data Analytics compatible to FDA Quality Metrics program - Hands-free Process Validation, Training, Design Transfer and DHF Support documentation using "Smart Glasses"​ - On-Premise or SaaS Quality System offerings - Setting up QMS and SQA policies - Center of Excellence (CoE) - Setting up and running CoE models using Onsite/Offshore delivery models - Support with Computer System Validation, Process Validation, Equipment Validation, Cleaning Validation, Medical Device product validation & Quality Engineering (CAPAs, NCRs, Complaints, Supplier Quality execution) - Audit/Inspection Readiness Assessments – If there is an impending Internal Audit or an External Regulatory Agency Inspection, we can perform Audit Readiness Assessments and deliver prioritized remediation activities - Supplier Quality Audits – Our certified Auditors can perform Supplier Quality audits and provide intelligence on Supplier Quality. - Remediation Packages – Packages to address Consent Decrees, 483s, Warning Letters and Data Integrity Issues - Process Improvement Packages - Serialization/UDI - Setup & end to end line validation/compliance