We have expertise and offer support in many areas, including the following:

1. Medical Device Regulation Strategy:

Our regulatory plans can include all aspects of the device's development and marketing, or they might concentrate on certain issues like device modifications or regulatory requirements. A medical device regulatory strategy is a great way to start a project and prevent any unpleasant surprises. It starts by defining whether the product meets the definition of a medical device in the geographic location, determining which regulations and standards apply, and laying the groundwork for the testing strategy required.

2. Classification of Medical Devices:

Our determinations are based on years of experience implementing the classification rules, and we provide sound justifications for the choice. We can provide classification determinations for devices in any geographic location, whether it be through reviewing the classification rules in the EU, Canadian, or Australian medical device regulations or searching the US FDA device classification database.

The majority of categorization choices are quite simple to make, but others call for a comprehensive examination of the guidance materials, judgements made for other similar devices in use or court cases where related problems have been raised.

3. Biological Evaluation Plans and Reports (ISO 10993):

A thorough biological evaluation strategy and report is necessary for any device that comes into touch with a patient or user directly or indirectly. This will speed up regulatory approvals and reduce complaints about adverse occurrences while in use. Due to the expertise and experience of our specialists in conducting biological tests, any potential toxicological effects will be rapidly and accurately recognised.

4. Transitions in Medical Device Regulation (MDR):

The MDR's delayed implementation date is quickly approaching, and there won't be much longer after that during which medical device directive (MDD) certificates will still be valid, therefore it's crucial to use an up-to-date transition plan. We can do a thorough evaluation to find these gaps and help determine the most effective method to close them, whether it's detecting weaknesses in technical files, clinical data, or quality management system needs.

5. Technical Documentation/Technical File:

Producing a clear and thorough set of technical documentation for the regulatory authority or notified body to assess is one of the greatest strategies to guarantee quick market access. Using the most recent guidelines, we can ensure that all necessary information is included and organised in a way that is simple to discover, understand, and review, which can shorten review times, lower costs, and speed up approvals.

6. Plans and Reports for Clinical Evaluation:

Whether the clinical evaluation is based on clinical data obtained from a literature review of comparable devices or on clinical data available on the device itself through clinical trials and post market surveillance, we can provide clinical evaluation plans and reports to meet the requirements of the MDD or MDR and pertinent guidance documents. This includes taking the lead on or providing assistance for the work necessary to show equivalence to other products on the market.By utilising all available data, the best literature search methodology, and the use of justifications for not requiring clinical data for certain low-risk devices with a simple interaction with the user, the majority of clinical evaluations are able to obtain enough clinical data to demonstrate the device's performance and safety.

7. Post Market Surveillance:

The MDR and IVDR's adoption has sharply raised the emphasis on post-market surveillance. We can assist in creating the most suitable post market surveillance plan and post market clinical follow-up (PMCF) plan for the circumstance thanks to our awareness of the pertinent needs and experience in how to best satisfy them. This can be accomplished by making the most of already established methods for gathering PMS and PMCF data as well as by creating custom studies to effectively fill in any gaps in safety or performance data. The majority of clinical studies are able to gather enough clinical data to show the device's effectiveness and safety by utilising all accessible data, the most effective strategy for literature searches, and the use of same in our medcial device.

8. Premarket Notification 510(k):

From the careful selection of predicates and, where necessary, reference devices and deciding on appropriate testing, through compilation of the 510(k) and responding to any information requests from the FDA reviewer, we can help with all aspects of compiling and submitting 510(k)s for marketing pertinent devices in the US.