Dor provides focused solutions specific to address regulatory requirements in the medical device industry. Services support Israeli companies that manufacture for local and international consumers, as well as importers to Israel. Dor works with all device classes (medical devices, active implantable medical devices and in vitro diagnostic medical devices), the United States (medical machine, contrivance, implant, in vitro reagent, or other similar or related article – Class I, II and III devices) and other countries.
Customers benefit from Dor’s device expertise and experience across the regulatory spectrum, for the following services:
Dor helps device manufacturers, importers, exporters and distributors obtain and maintain compliance, supporting the entire product lifecycle, from pre-market approval registration to maintenance of existing licenses.
Devices for use in Israel
For companies manufacturing locally or importing for Israeli use, Dor offers the following essential solutions:
- Regulatory affairs department outsourcing
- New product submissions and follow-up till approval
- Post-approval support (renewals, variations, import issue resolution, extensions for additional indications/uses, device vigilance, etc.)
- Business development and due diligence
- Regulatory affairs consulting
- Regulatory second opinions
- Special import permits and annual import permits
Devices for export
For Israeli-made devices targeted for export, Dor supports the registration process to ensure compliance with international directives that demonstrate product safety, quality and effectiveness. Export registration services cover Europe (CE Marking), the United States (510K, PMA) and countries in Asia and Africa.
Medical Device Packaging, Labeling & Localization
Dor provides end-to-end device labeling and localization solutions for packaging, inserts and labels, delivering added production value in the complex and dynamic Israeli legislative environment. Dor adapts and translates all labeling elements to local regulatory requirements, formats and languages, graphically designs artwork and prints all packaging elements, with attention to detail and timely delivery. Read more >>
Dor helps manufacturers develop and support quality management systems to meet ISO 13485 requirements, proving quality in the design and manufacture of medical devices. Companies can also rely on Dor for GMP and GDP compliance audits.