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