How We Work With Our Customers
DDL takes pride in providing its customers thorough test documentation and accurate results. It’s one of the strengths that brings medical device manufacturers back to DDL again and again.
Our customers prefer DDL’s test reports because they are presented professionally with a high degree of detail … including precise documentation of test results in an easy-to-understand format. Reports are illustrated with photographs showing test services and their results.
Each report is thoroughly reviewed, before it leaves our lab, for technical accuracy and quality assurance, as well as compliance with every aspect of our customer’s request.
DDL is your one-stop shop for your product, process and package testing validation. By writing thorough protocols, we will guide you through the methodologies we use to complete your testing project.
The protocol is tailored directly to your product and/or package and sample size. The protocol we design for you will satisfy the ISO 11607 standards requirement for sterile medical packaging.
Submission of your complete formal test report to the Food & Drug Administration will bring you closer to validation in the European market or CE mark.
Pricing and Terms
You can count on DDL’s comprehensive, clear fixed-base cost estimates. We stand by our quotes so there will be no surprises.
Test reports detailing the test methods and results are provided on request at an additional charge. If no report is requested, reviewed and approved test data will be supplied with a cover letter indicating the test standard that was performed.
Test Reports are reviewed by our technical and quality assurance personal to ensure accuracy as well as professional standards.
DDL takes pride in its superior customer consultation and fast turn-around time when it comes to project management.
DDL project managers work closely with the customer, from the initial quotation to closing out the project with final documentation, technical and quality reviews, and return or disposal of the test specimens.
It is the project manager’s role to consult with the customer over package, product and material testing requirements to ensure that a testing project can be closed out within the given time frame.
At the beginning of the project, DDL consults with the customer to determine and confirm:
- Project Scope
- Test Sequences
- Applicable Industry Standards
- Types of Testing Services
- Sample Size
- Labeling Requirements
- Disposition of Specimens Before & After Testing