Quality Manual, Policy and Objectives
Contents
Quality Manual, Policy and Objectives#
ISO 13485:2016 Section |
Document Section |
|---|---|
4.1.1 |
1. |
4.1.2 |
4. |
4.2.1 b) |
(All) |
4.2.2 |
(All) |
5.3 |
2. |
5.4.1 |
2. |
Summary#
The Quality Manual describes the scope of the Quality Management System, its documented procedures and a description of their interactions.
1. Scope#
The QMS described in this Quality Manual applies to all products of Radiotherapy AI Pty Ltd.
Role of Company#
Radiotherapy AI Pty Ltd is a manufacturer of Medical Devices.
Applicable Standards#
Standard |
Why Applicable? |
|---|---|
Therapeutic Goods Act 1989 |
The Act for all Medical Devices Manufacturers in Australia |
Therapeutic Goods (Medical Devices) Regulations 2002 |
The regulations for all Medical Devices Manufacturers in Australia |
MDR (2017/745/ |
Regulation for all Medical Device Manufacturers in the EU |
ISO 13485:2016 |
QMS utilised to meet the TGA essential principles |
ISO 14971:2019 |
Risk management for medical devices |
IEC 62304:2006 |
Software development for medical devices |
IEC 62366-1:2015 |
Usability evaluation for medical devices |
Exclusions#
The following sections of ISO 13485:2016 will be excluded due to the product being stand-alone software:
6.4.2 Contamination control
7.5.2 Cleanliness of product
7.5.5 Particular requirements for sterile medical devices
7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems
7.5.9.2 Particular requirements for implantable medical devices
2. Quality Policy & Objectives#
Quality Policy#
Radiotherapy AI Pty Ltd aims to use AI to save lives within radiotherapy. To achieve this it has the goals to reduce treatment errors and improve treatment efficacy while helping more patients to be treated through efficiency gains.
Quality Objectives#
It is the objective of Radiotherapy AI Pty Ltd to provide best-of-class device performance while obtaining high standards of customer satisfaction.
Device performance is governed by the underlying algorithm as well as the overall software quality.
When tracking the quality of the AI autocontouring software its results are compared to health practitioner ground truth contours over a range of datasets that have not been used for model training. These comparisons are undergone utilising the following metrics:
Hausdorff
Surface and Volumetric Dice
Four point health practitioner approval scale
Software quality is tracked through the following objectives:
Minimisation of reported defects
Software uptime
Software maintainability
Customer satisfaction is tracked through user feedback. Various objectives based on achieving customer satisfaction are:
Timely support
Software performance
Ease of use and installation
Short-Term Goals#
Software development goal tracking is managed through the GitHub issue system. See https://github.com/RadiotherapyAI/rai/issues.
3. Roles#
Role(s) |
People |
|---|---|
CEO |
Simon Biggs |
QMO |
Simon Biggs |
PRRC |
Simon Biggs |
CTO |
Simon Biggs |
Advisor |
Stuart Swerdloff |
Regulatory Consultant |
Dr Oliver Eidel |
Regulatory Consultant |
Pierre Lonchampt |
All C-level roles are referred to as the Management. Management is generally responsible to define responsibilities and authorities, to define and communicate Quality Policy and Goals and to ensure that the whole organization is oriented towards them.
The Quality Management Officer (QMO) is responsible to:
ensure that processes needed for the company’s quality management system are documented
report to top management on the effectiveness of the quality management system and any need for improvement
ensure the promotion of awareness of applicable regulatory requirements and QMS requirements throughout the organization.
Person Responsible for Regulatory Compliance (PRRC) Responsibilities of the PRRC are in accordance with Art. 15 MDR as follows:
Ensure (review / release) the conformity of the devices is appropriately checked in accordance with the QMS before a device is released (also see Art. 10 Para. 9 MDR)
Ensure (review / release) that the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date for all medical devices (also see Art. 10 Para. 4 and Art. 6 MDR)
Ensure (review / release) that obligations for post-market surveillance are complied with in accordance with Art. 10 Para. 10 MDR
Ensure (review / release) that the reporting obligations of Articles 87 to 91 MDR are fulfilled (FSCA / incidents, also see Art. 10 Para. 13 MDR)
Ensure that, in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV MDR is issued.
The PRRC shall not be subjected to Management instructions while carrying out his/her responsibilities specified above. His/her tasks may be delegated to other roles as long as it is ensured that final responsibility stays with the PRRC. She or he has the power and authority to represent the company in the scope of his/her responsibilities, e.g. in communicating with state authorities.
Required qualification for this role:
Fluent in English language
Knowledge of the role and responsibilities of a ‘Person Responsible for Regulatory Compliance’ according to Art. 15 MDR
Higher education degree in law, medicine, pharmacology or engineering OR: four years of professional experience in the fields of quality management and regulatory affairs
At minimum one year of professional experience in the fields of quality management and regulatory affairs
4. Processes#
SOP |
Process Category |
|---|---|
Core |
|
Core |
|
Core |
|
Support |
|
Support |
|