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Med QMS

Medical Devices QMS and Regulatory Affairs Melbourne

For all your Medical Device Quality Assurance and Regulatory Affairs needs

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Services

Get It Right First Time, Every Time.

Medical Device Quality System Setup
ISO 13485:2016 and 21CFR820

quality system
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.

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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

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quality solutions processes procedures policies

QMS Audits

Make sure you’re ready for certification body’s audit!
internal external suppliers audits

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
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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.
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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.
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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.
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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:

  • 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
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regulatory affairs

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.
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Contact us for a customised quote for all your Quality Assurance and Regulatory Affairs requirements.


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ISO 9001 ISO 13485:2016 MDD 93/42 EEC / MDR CMDR (Health Canada) 21CFR820

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Med QMS

For all your Quality Assurance and Regulatory Affairs requirements.

+61 410 717 106

alexander@medicalqms.com.au

Melbourne based

Elsternwick VIC 3185
Australia

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Our Services

  • All Services
  • QMS Services and Audits
  • Regulatory Affairs
  • QMS Setup
  • Regulatory and QMS Training
  • TGA Sponsor Representation
News and Updates

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About

With 20 years’ experience in the medical device industry, both managing Quality, and Regulatory Affairs and as an active auditor, we can be counted on to deliver the systems, documentation and advice required.
We pride ourselves on having achieved 100% compliance for all our clients. Continue reading …

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