Assistance with developing regulatory program strategies
The regulatory program for a start-up company has to be developed and implemented well before the first product can be manufactured. For established companies regulatory programs need to be maintained, regularly reviewed to ensure that regulatory requirements continue to be met and even need to evolve as a product range changes.
Slate Hill Consulting can assist your company to develop the necessary strategies for a regulatory program at any point along your development timeline.
Assistance with developing post market surveillance programs
Before a medical device can be supplied a manufacturer will need to develop surveillance programs to monitor the market where their products will be supplied. These programs need to collect information that the manufacturer can use to ensure their products continue to be safe and effective.
Slate Hill Consulting can assist your company develop a post market surveillance program, review the effectiveness of current programs or provide assistnace when improvements may be needed.
Conformity assessment certification advice
A manufacturer of a medical device is required to develop systems and programs to assess the safety and effectiveness of their products against the legally prescribed set of essential principles. Depending on the risk classification of the devices, those programs may need to be independently inspected and certified before the products can be approved for supply.
Slate Hill Consulting can assist your company to develop conformity assessment programs and review established programs before inspection and certification. Advice can also be provided on improvements following conformity assessment inspections.
Pre-auditing or pre-inspection reviews
If a manufacturer’s conformity assessment system needs to be inspected, either before certification can be issued or as part of a surveillance inspection program, an independent pre-audit or pre-inspection could identify potential issues before the certification inspection.
Slate Hill Consulting can review your company’s internal conformity assessment systems and can advise on improvements.
Regulatory submission advice
Applications have to be submitted to the Therapeutic Goods Administration to supply a medical device or for a conformity assessment inspection. An independent review of the applications may identify shortcomings or potential improvements which could improve the likelihood of a successful application.
Slate Hill Consulting can review your company’s applications to the TGA before they are submitted or review previous submissions to assist with improving the quality and effectiveness of new submissions.
Regulatory training programs
Medical technology companies need to ensure that their regulatory staff have the right skills when they join the company as well as making sure they understanding any impacts of changes to legislation or other requirements.
Slate Hill Consulting can compile a training program to improve the current skills and knowledge of the regulatory staff of your company as well as conducting training programs for new staff members.
Promotion and advertising material review
Although advertising or promoting medical devices to the general public currently does not require prior approval, any promotional material has to be truthful and consistent with the intended purpose of the device. However the the supply of any therapeutic good, including medical devices, can be stopped by the Therapeutic Goods Administration if breaches of the Advertising Code are not adequately rectified.
Slate Hill Consulting can review your company’s promotional material for medical devices before they are supplied. Advice can also be provided if complaints are raised about the promotional material.
Coaching programs for regulatory staff
A formal training program for regulatory staff may not be the most cost effective option for some medical device companies. A program to coach or guide staff in their day-to-day activities as they work through submissions, applications or responses to the Therapeutic Goods Administration may be a better alternative.
Slate Hill Consulting can develop coaching programs specifically for your company and then work directly with your regulatory staff to help improve their skills and expertise.