Medical Device Consultants
A diverse team of experienced medical device professionals in Australia.
Our team of medical device specialists offers you, complete focus on the Australian medical devices industry.
We perform the following main services for our Medical Device and IVD clients:
1. Medical Device - Regulatory and Quality Compliance
The first step to selling products in Australia is establishing the regulatory landscape. Our consultants have extensive experience in the area.
- TGA regulatory registering compliance requirements.
- Registration and Quality Systems requirements
- Comprehensive knowledge of Australian business culture and ethics.
2. Market potential and entry strategy for Australia.
- Listing of competing products on sale in Australia.
- Ideal Australian medical distributor profile.
- Optimal service and logistics structure.
3. Australian medical device distributor qualification and selection
Thorough pre-qualification of Australian medical distribution partners based on needs.
- Intensive screening of medical device distributors
- Evaluation of experience, service level, etc.
- One-on-one interviews to determine a "short list" of qualified candidates.
- On-site evaluation of "short list" medical device distributors.
- Final selection by client.
4. Australian medical device distribution network management
- Liaison between your company and medical distribution partners (distributors, logistics and other service providers).
- Assistance with troubleshooting, recalls and TGA interaction.
- Auditing, contacting or visiting your selected Australian medical device distributors to conduct compliance and marketing audits.
- Monitor new / competing products.
- Monitoring medical device distributor performance and provide quarterly reports on sales, service, promotional activities.
- Contacting or visiting your logistics and other service providers to conduct quarterly performance audits.
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Validation
GMP Compliance
Drug / Medical Device Registration
Lean Pharma