In the fast changing regulatory environment, our regulatory professionals stay up to date on current standards and regulations. We have a track record of obtaining conformity for our clients’ products under difficult situations and under tight timelines.  We assist in Life Sciences, Pharma, Medical Devices and Bio-Med enterprises to comprehend and effectively manage the demanding complexity of Regulatory regulations in order to successfully launch products in new countries and maximize market value. Our area of expertise include Regulatory Submissions (EU MDR, FDA 510k, PMA, IDE, EUA, CE Mark & Compliance and Q-submissions), ISO 13485 and FDA compliance evaluations, FDA (483 Observations, Warning Letters, Consent Decrees) Remediation, Technical File & Design Dossier Preparation,  Global regulatory strategies like FDA 513 (g) and EU MDR 2017/745 gap assessments and transition. We develop, implement, and maintain integrated quality management systems that comply with regulations in all major medical device markets, including:

To drive innovation in a way, we deliver specialized scientists & Engineers focusing on accelerating successful Research & Development processes.  We provide assistance in transforming therapeutic concepts into tangible products. We help to create an effective product vision and develop a fit-for-purpose R&D strategy and project plan towards the vision. We ensure that at each project stage, the plan reflects key requirements for successful development of novel treatment (proof-of-concept, developability and differentiation) and includes checkpoints with predefined acceptance criteria.

For ongoing projects, we offer an independent scientific review and advice on the recommended direction or corrective actions, as well as the assistance in outsourcing of project-related activities. We also provide project managers for clients who provide cross-functional core team leadership, building consensus, and driving stage-gated Research Development processes forward without exceeding budgets or timelines from concept to commercialization.

Our Design Quality Engineers assures the devices meet user needs, intended use, and specified requirements. Attention to design and development planning, identifying design inputs, developing design outputs, verifying that design outputs meet design inputs, validating the design, controlling design changes, reviewing design results, transferring the design to production, and compiling a design history file we provide expert Design Quality Engineers ensuring interpretation and application of the latest regulations, to bring your systems into compliance with MDR, IVDR, or ISO 14971:2019. Including implementation of current best practices and integration of risk management with PMS and clinical activities.

Developing biocompatibility techniques that take into account gaps in materials, design, and process in order to achieve optimal solutions that meet biological safety timeframe, cost, and technical requirements. We specialize in seeking an experienced, high-caliber Biocompatibility Scientist that will contribute to patient safety by assisting with biocompatibility projects/programs for medical devices, materials, and processes.

Commissioning, qualification and validation services are important factors to ensure facilities, utilities and equipment perform as intended. Our experienced Validation Engineers worked for many years in the industry and have developed formidable library of key project documents, ranging from Validation Master Plans, User Requirements Specifications (URS), Functional Specifications (FS) and Detailed Design Specifications, IQ, OQ, PQ. Weutilize a risk-based approach to qualification that aligns current regulatory requirements with your unique business constraints and customize each validation package.  Our expertise services include:

Our senior Engineers, who have years of professional experience in a wide range of health care systems and electronic quality management systems, will assist your company with skills and advice, strategies and design, and collaboration with software developers to build software to elevate your business standards and adhere to regulatory guidelines.  We provide a broad range of Computer System Validation (CSV) services in support of manufacturing, laboratory, and enterprise systems.

By verifying the controlled development and implementation of computer systems, we ensure the integrity, reliability, and availability of regulated business data to support the production of quality products and protect patient safety.

Our team of professional experts analyses your requirements and matches you with qualified candidates. Whether you require packaging for a new product, want to rework an existing design or need to remediate packaging issues, our packaging engineers have the experience from concept generation through commercialization. We provide full packaging engineering services for pharmaceutical and medical device applications, we utilize engineering capabilities to design primary, secondary and tertiary packaging for configurations and materials used in pharmaceutical and medical device packaging. Our designs meet testing standards and demonstrate compliance to ISO 11607 Part 1 and Part 2.

Companies that are dealing with new technologies, process optimization, or manufacturing development might benefit from our Product Engineering and Manufacturing services. We specialize in assisting the work closely with your product development team to find the technologies that will enable you to attain the best design, materials, and manufacturing capabilities.We work with companies to meet Certified Good Manufacturing Practices (CGMP), FDA requirements and ISO requirements. Additionally, we help companies moving from batch to continuous production in order to reduce waste, while also leveraging traditional improvement and quality methods that have been deployed throughout industry. Some of the industry challenges we solve include:

Our team of Supplier Quality Engineers will use their knowledge to bring your quality system into compliance with federal laws and give regulatory intelligence to help you design new procedures and systems. Our specialized services for your supplier development needs include:

Complaints Handling

We assist the companies to document the complaints handling process, help you to understand the objectives of compliant handling within the context of overall Quality System and  Corrective and Preventive Action (CAPA) subsystem. Our services include:

Our expert Medical/CER write or conduct a clinical evaluation as per EU MDR 2017/745 Article 61, examine clinical data sourced from various sources to conclude the subjected medical device is safe and performing well for the intended purpose. Our team has extensive experience in medical writing, data analysis and, as experienced writers of CERs, are able to support any medical device manufacturer. We provide specialized services in writing Clinical Development Plans (CDP), Clinical Evaluation Plan (CEP) and Clinical Evaluation Reports (CER) in compliance with MEDDEV 2.7/1 and MDR 2017/745 including defining evaluation strategy, performing literature search, interpreting PMS and PMCF data,  and completing final clinical risk benefit analysis.

We are a customer-focused, technology-driven organization that provides information technology, product engineering, and enterprise application development services to assist our customers create value from their software development outcomes. Use the expertise and deep tech background of the best minds to create a comprehensive IT strategy for a digital and technological transformation of your organization that goes in line with your business objectives. Our strategic IT consulting will help you automate and digitalize operations, optimize the software portfolio, and implement the latest technologies.