Medical Device Quality System Setup
ISO 13485:2016 and 21CFR820
Beneficial for start-up companies who are new to medical device regulations, this service delivers a systematic approach that will take you from zero to compliant. We’ll create an implementation plan and then go ahead and set up all the necessary structures and documentation. Our advice is considered, methodical and pragmatic – you’ll know where you stand every step of the way.
QMS Solution
A Quality Management System (QMS) is critical to an organisation’s ability to develop products and services and successfully deliver those to market to meet customer requirements. In the area of medical device QMS, we are highly experienced in delivering the following QMS solutions:
- Gap analysis for an existing QMS
- Setup Standard Operating Processes and Procedures
- Validation activities such as process validation (IQ/OQ/QP) and validation of software used in production and service provision
- IEC 62304 – medical device software – software life cycle processes
- IEC 62366 – Application of usability engineering to medical devices
- EN 60601-1 – Medical electrical equipment
- Risk assessment (ISO 14971)
- QMS training
QMS Audits
Make sure you’re ready for certification body’s audit!
MDSAP Audit
We help you to prepare for a Medical Device Single Audit (MDSAP). This program allows the conduct of a single regulatory audit of a medical device manufacturer’s QMS, to satisfy the requirements of multiple regulatory jurisdictions.
Countries covered under the MDSAP:
- Australia
- Brazil
- Canada (MDSAP audit is a mandatory requirement for a manufacturer selling medical devices into Canada)
- United States
- Japan
Internal audit
We help you prepare, maintain and execute an Internal Audit program to maintain compliance with ISO 13485, 21CFR820 and other standards. We provide advice on the findings resolution.
Desktop Audit option is available for international clients.
Pre-audit
We perform a pre-audit to simulate a real 3rd party audit (ISO 13485, MDSAP and 21CFR820) to verify company readiness and to provide training on the external audit process.
Desktop Audit option is available for international clients.
Supplier audit
Unsure if your supplier is capable of performing the tasks you need? Or if they comply with regulatory requirements? Don’t get caught short. It’s your responsibility to ensure your supplier is doing the right thing and that they fulfill all your company’s requirements. Let Medical QMS take care of the Supplier Evaluation Process and act on your behalf by performing an audit of your suppliers.
Desktop Audit option is available for international clients.
Regulatory Affairs
Regulatory affairs services are critical to a medical device’s product lifecycle and therefore specialist advice must be sought before, during and after the launch of a new device. Every company that innovates in this arena seeks to offer a more effective treatment to a particular condition or disease and improve patient outcomes; therefore it’s vital that compliance and regulatory affairs responsibilities are taken seriously.
We offer the following regulatory affairs services:
We offer the following regulatory affairs services:
- Definition of a regulatory strategy for local or global markets including pre-market strategy, regulatory submissions and post-market compliance.
- EU registration – we will compile technical files for your product to comply with MDD/MDR requirements.
- TGA (Therapeutic Goods Administration) registration – the TGA is a unit of the Australian Government’s Department of Health and Aging which oversees medical device regulation in Australia.
- Review of marketing materials for compliance based on region-related regulatory requirements.
- Transition from MDD to MDR
Australian TGA Sponsor Representation for Medical Device Companies
If you are not an Australian resident and wish to make available your medical device in Australia, contact me to find out how I can provide sponsorship.