R&D and Registration/Registration
Medical Devices
Classes I, II, III and IV
From concept to
production: one
complete project
Our service covers all the necessary steps for development.
medical devices:
Planning
Technical project
Prototyping
Validation
Clinical and laboratory trials
Regulatory registration
Transfer to production
Project Stages
The process is divided into 22 well-defined phases, ensuring clarity, traceability, and quality at every stage.
01
Definition of the Predicate
Consolidated Product Reference for Project Design
02
Definition of Raw Materials for Implants and Instruments
Definition of NCM for Implants and Instruments
03
Implant Design (3D)
Instrument Design Project (3D)
04
Manufacturing of Implant Prototypes for Design Validation
Prototype Validation
06
Drafting the Protocol
of Essays
05
Risk Management Development
07
Definition of Critical Models for Mechanical Testing
Definition of Critical Models for MRI Testing
Definition of Critical Models for Biocompatibility
08
Preparation of 2D Drawings of Critical Implant Models for
Pilot Batch Production
09
Creation of the Manufacturing Process for the Pilot Batch Implants
10
Manufacturing of the Pilot Batch of Implants for Mechanical Testing
Monitoring the Manufacturing of the Implant Pilot Batch
11
Costs of the implants that were manufactured
Pilot Lot
Note: Assess the need for
manufacturing of items not covered in
Pilot Lot
Price vs. Margin Validation
Contribution of Implants that were
Pilot Batch manufactured
First possibility: Based on a price of
existing market.
Second possibility: Based on the costs already calculated and in accordance with the company's goal.
12
Mechanical tests
Follow-up
of Mechanical Tests
Critical Analysis (Evaluation of Mechanical Test Results)
Review of the Critical Analysis Report of the Mechanical Test Reports
13
MRI Trial: Critical Analysis and Report Review
of the Essays.
Optional for Cost and Time Reduction:
Technical Defense through Report Preparation
with the use of data from AREEs (Equivalent Foreign Regulatory Authorities), product equivalence, and the presentation of robust technical dossiers.
14
Biocompatibility Tests: Critical Analysis and Review of the Test Report.
Optional for Cost and Time Reduction:
Technical Defense: The strategy consists of carrying out
only the strictly necessary tests,
using data and information already existing in scientific and regulated databases to justify not performing repetitive or irrelevant tests for the medical device in question.
15
General Data Collection for Clinical Evaluation
16
Clinical Evaluation (A set of ongoing activities that use scientifically sound methods to evaluate and analyze clinical data in order to verify the safety and clinical performance of a medical device when used as intended by the manufacturer)
17
Evaluation of the Special Processes Involved in the Project.
18
Tryout Production
Instruments
Monitoring the Manufacturing of Instrument Tryouts
19
Usability Workshop / Report
20
Technical Dossier: Preparation / Evaluation (Gap Analysis) and Assembly.
Submitting a Product Registration Petition to Anvisa .
21
Preparation and delivery of all 2D drawings of implants and instruments.
22
Documentation of the Project's Historical Record in accordance with Client Procedures: Transfer of the Project to Production
What
Can we develop it?
Our process applies to various types of medical devices:
Implants
orthopedic
Instruments
surgical
Devices
customized
in 3D
Products with
requirements
special
Turn your idea into an approved and safe product.