HaMaDa is a Medical Device, Life Sciences, and Digital Health professional services firm dedicated to guiding these types of companies to successful launch and sustain products in the international marketplace.
The medical device & Life Sciences 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 is especially true in the fast-paced world of medical software development.
The same is true with executing of clinical studies in Pharma, Biotech & Medical Device industry – you need experts to manage these processes correctly, accurately and cost sensitive.
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 for well established companies. For early stage companies, we can help define the best strategic and tactical plans to pave the way into the market and assist in implementing these plans. For well-established companies, our experience can complement in-house expertise to assist with specific quality and regulatory activities. We can also provide training for personnel and execute internal audits of your QSR and/or ISO 13485 quality system.
By providing regulatory strategic planning, ongoing regulatory support, submissions to regulatory authorities of complicated documents such as PMS, CER or study articles, HaMaDa can be your home for all your regulatory, QA and clinical needs.
Our CRO services the Medical Device, Biotech and Pharma industry. HaMaDa will become your essential partner in the success of new products in the market.
Our service is needed along the life cycle of the product development and sales
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Our current client list includes medical devices, digital health solutions, IVDs, combination products, invasive and non-invasive devices, cannabis technologies, treatment and diagnostics, Pharma companies and more. Among our customers you may find the following:
HaMaDa offers unique capabilities in supporting members of the Medical Device, Digital Health, Biotech and Pharm industries at meeting their Clinical, Regulatory & Quality/Compliance requirements, goals and timelines.
Our services include:
Development of regulatory strategies; Guidance in the implementation of regulatory requirements through the Design and Market Phases; Regulatory Submissions (FDA, CE, Global Regulations); Support ongoing regulatory tasks such as risk management, complaint management, CAPA & ECO processes; SW QA; Cybersecurity; Information Privacy, registration & listing and more.
Establishment,implementation & maintenance of Quality Systems to comply with ISO 13485, MDR, IVDR, MDSAP & FDA-QSR; Execution of quality audits and mock FDA audits; Vast experience with FDA compliance requirements and implementation; QA Engineering tasks, V&V support; Remediation projects.
Clinical Strategies, writing the required clinical documents in the Medical Device and IVD industry including CEP & CER, PEP & PER, PMS, PSUR, PMCF, SSCP; Scientific Writing; literature Surveys; Articles; Clinical Study Protocols and Reports.
Full CRO services, submission packages to IRBs, CIP; IB; ICF; CRF; Management and conduct of clinical studies from submission to initiation, monitoring until study closure. Developing Customers compliance to GCP; development of EDC/eCRF and eTMF.
