Service / OEM Manufacturing

With over a 120 years of experience, MORSA Dental  can  OEM - manufacture a comprehensive range of Own Brand Products to your individual requirements. This includes an extensive range of dental  waxes ( especially baseplate waxes) for Laboratory and Dentists 

Consult us to increase your market share. 

Normally we would initiate the process by consulting with you to gather as much information from you about your desired product and ambitions for your brand.

We would discuss the following in detail: 

  • specifications
  • Target markets
  • pricing

either by email, phone, skype or in a meeting.

As a leading OEM / private label producer according to ISO 13485 and the new MDR  we can provide you with the following Master Record files according to MDR :  

Content

Main Records

Series

Company Profile

 Group of Users / Targeted Patients

Products

Product Description      

List of Products

Product Images

              Properties of Material

              Chemical Composition

Technical Properties

               Intended Use

               Contraindication

               Suppliers

               Process Description

               Validations

               Mechanical Technological Tests

               Training of Users

               Risk Management

               Product Circle of Life

               Training  of Users

               Usability

               Biological Evaluation

               Tests according to ISO 10993

               Clinical evaluation

 Service Life

               Arangement for representation in absence

               Responsibility internal documents

               Records of quality

               EU-Regulations MDR 217/745

               Appendix I (General Requirements)

               Appendix IV (Declaration of conformity)

 Appendix VIII (Classifications)

               Instructions for Use

               Labelling and packaging

               Angewandte Normen

               Technical records

               List of responsible authorities

               PMS - PMCF (accord. To MEDDEV 2.12/1)

 Master record – creation/drafting, approval. release

Clinical Evaluation

General Requirements

Instructions for Use

Labelling and Packaging

Risc Management

Biological Evaluation

Declaration of Conformity

Physical Scrutiny

Usability

MSDS & Data Sheets

Post Market Survaillance

Working Instructions

Regulations  for emergency and recall

Templates

Kauf auf Rechnung mit Ihrem Depot.

Schnell und direkt beim Hersteller bestellen und wie gewohnt über Ihr Depot verrechnen.