Capabilities

Our company ensures that through the ups and downs – we are there to provide guidance and support.

At Medimor, we understand that medical device development is a long term process. We assure you the utmost patience in delivering solutions to all challenges that may be encountered.

Regulatory Compliance

We have a company-wide commitment to quality and regulatory compliance.

Medimor’s facilities comply with internationally recognized standards for medical devices; as well as health and safety requirements. Medimor ensures compliance through its well-established Quality Management System and by implementing its Quality Management Policy. This ensures that all products are always manufactured using reliable, repeatable, and compliant processes.

Medimor is committed to maintaining a high standard of corporate responsibility to Environment, Health and Safety (EHS), which is integral to its corporate philosophy. We believe our products play a significant role in improving people’s lives.

ISO 14001: 2015

Environmental Management Standard

ISO 13485: 2016

Notified by Dekra. Medical Devices, Quality Management Systems

ISO 45001: 2018

Clean room monitoring and controls

OHSAS 18001: 2007

Occupational Health & Safety Management standard

IMC Israeli Medical Cannabis

GMP by the Israeli Ministry of Health (“Yakar”) since 2018

FDA registered site

CFR21 PART 820

Engineering

Medimor delivers a range of value added engineering services to provide you with a holistic solution.

We take a methodical approach throughout your product’s life cycle to bring new value to the development process.

Continuous improvement to the production process by combining traditional methods with advanced data collection in order to increase throughput and improve production yields.

Validation – Process Failure Mode Effects Analysis (PFMEA) risk assessments to ensure successful Validation & Verification (V&V) process, MVP – Master Validation Plan, MSA – Measurement System Analysis, PV – Process Validation.

Providing a variety of services under the same roof such as:

  • Automation
  • Jigs and fixtures
  • Testing equipment
  • Configuration management
  • Reliability tests
  • Software design
  • Medical cleaning process
  • Bio burden reduction
  • Microbiology investigations

Manufacturing

Medimor provides turnkey manufacturing and NPI solutions for medical devices.

Electronics & SMT

Clean Room Assembly

Assembly & Integration

Parts Cleaning and Sanitation

Medical Cannabis Device Manufacturing

NPI

Our range of services and expertise enables us to integrate seamlessly with your development-to-production process. Whether you are in the prototype stage, or whether you require a build to print manufacturing solution, we will that you are provided with high-quality support and service.

Facilities

  • Clean rooms ISO 7 Class 10,000
  • Clean rooms ISO 8 Class 100,000
  • Assembly production hall
  • Purified Water systems complies with USP for cleaning purposes
  • Environment controlled SMT room ISO 9
  • Environment controlled warehouses