Regulatory, Quality and Clinical Services for the Medical Device and Digital Health Industry
HaMaDa is a Medical Device, Life Sciences, and Digital Health consulting firm dedicated to guiding these companies to successful launch and sustain products in the international marketplace.
The medical device industry is a heavily regulated industry which may seem intimidating. Global regulation of medical and digital health products is a very complex and constantly changing environment. It’s not just about submitting files to the US FDA or the European authorities. Regulatory compliance, clinical efforts and ongoing quality assurance must be an integral element of a corporate strategy.
Effective regulatory guidance will build confidence in your product’s capabilities while helping you to avoid potentially costly consequences. The difference between a mediocre and a good regulatory strategy is the difference between success and failure. This especially true in the fast-paced world of software development.
HaMaDa has the vital experience necessary to expedite the regulatory approval process and provides a wide range of services, for start-ups as well as established companies. For early stage companies, we can help you define the best strategic and tactical plans to pave your way into the market and assist in implementing the plans. For well-established companies, our experience can complement in-house expertise to assist with specific quality and regulatory activities, as well as provide training for personnel or execute internal audits of your QSR and/or ISO 13485 quality system.
By providing regulatory strategic planning, ongoing regulatory support, submissions to regulatory authorities complicated documents such as PMS, CER or study articles, HaMaDa can be your home for all your regulatory, QA and clinical needs.
Our current client list includes medical devices, digital health solutions, IVDs, combination products, invasive and non-invasive devices, treatments and diagnostics. Among our customers you may find the following: