Medical Devices Compliance Reporting
Navigate complex industry regulations with confidence.
THE CONSTANT CHALLENGE TO MAINTAINING MEDICAL DEVICES COMPLIANCE
In the medical devices manufacturing industry, you face steep data quality compliance requirements, chemical reporting lists and submittal deadlines to keep your products on global markets.
- Requirements From Regulatory Authorities
Companies in the medical devices industry must meet requirements from governmental entities, often with shifting regulations and aggressive deadlines. These include REACH, SCIP, Conflict Minerals and RoHS.
- Requirements From OEMs Customers
Regulatory and quality requirements also come from OEMs and are sometimes even more demanding than those from regulatory authorities.
- Chemicals Reporting
Regulatory reporting in medical devices involves collecting chemical product data, both for what you manufacture and what you obtain from suppliers. Your access to the market depends on your accurate reporting.
Tetra Tech Experts — Here to Support You
With decades of regulatory experience, our Tetra Tech experts can help you efficiently navigate the changing requirements and complex supply chains of medical devices.
Expert, On-Call Team
Tetra Tech’s team has two decades of experience supporting customers in the medical devices industry. We can answer your regulatory questions and offer the support you need to report with confidence.
Custom Medical Devices Compliance Solutions
Compliance solutions must meet the challenges of a complex industry. From custom assessments and program implementation to software support, we are here to help you.
Regular Access to Online Resources
From industry insights to CDX and SCIP training, we have the resources you need. Access our regulatory insights, guides, training and tools online — anytime and anywhere.
Your Compliance Expert
AJ Guikema
Medical Devices Expert
With over 20 years of environmental and product compliance consulting experience, Mr. Guikema brings a unique expertise to all clients. Always up to date with the latest regulations and preparing for new ones — he’s ready to answer all of your compliance questions. | Connect on LinkedIn
Available Online
Training
Strengthen Your Regulatory Compliance
Program with Online Training Experience
CDX Training
Prepare full materials declarations and meet compliance regulations efficiently by using CDX for your non-automotive products.
SCIP Training
Meet SCIP database requirements for your EU market products with guidance from our compliance specialists.
Compliance Program Implementation
Assessments
Reporting Management
Online Training
UNCOVER SOLUTIONS FOR YOUR MEDICAL DEVICES COMPLIANCE NEEDS
With changing compliance requirements and aggressive deadlines in the medical devices industry, you want to keep your products on the market and meet regulations with confidence. Tetra Tech can support you in all your compliance needs.
