Techflakes Digital Private Limited

Medical Devices

The Medical Devices Industry landscape has changed as a result of a number of factors, including greater pricing pressure, demand for innovative products, operational inefficiencies and stricter regulations by regulatory bodies across the globe. Considering the changing landscape, the following are some emerging trends and innovations that the medical device industry is currently witnessing.

Innovations and Emerging trends in the Medical Device Industry:

Nanomedicine which combines nanotechnology with drugs or diagnostic molecules to improve the ability to target specific cells or tissues for imaging, diagnosis, or the delivery of drugs.
Minimally Invasive Surgery using Robots
3D Printing in the medical device industry is used to manufacture implants with complex designs.
Data digitization in assessment of product safety and performance, clinical trials, and supply chain, considering the stringent rules and database keeping by global regulatory bodies, such as Total Product Life Cycle (TPLC) management by the Food and Drug Administration (FDA)

Medical Devices Industry Players can generate the momentum needed for long-term growth and profitability by digitizing their business processes. Techflakes provides the following medical device industries related digital services to introduce new products while ensuring compliance to regulatory norms.

NPI and Regulatory Norms Complaince Services:

Build Device Classification

Configuration of FDA, EU Pre-Defined classifications in PLM tools and keeping it in sync with the changes

Design Controls Implementations

Configuration of Design Controls and implement & automate the process of Design inputs, outputs, verifications, validations.

Document Management

PLM tools provide very robust documents management capability. We can define templates, change control documents and classify them.

DHF, DMR, DHR Management

Medical Devices PLM tools provide the capabilities to create, maintain, manage these key deliverables.

QMS & Audit Management

PLM tools enables automations of the process required for QMS; it can manage & generate the documents required for Audit process.

CAPA & Reporting

PLM tools can manage the risks & issues in CAPA module and it can be configured to generate required reports.

While meeting regulatory norms is crucial to the medical device industry, equally important is its ability to bring innovative, cost-effective products to market quickly. Techflakes also offers the following services which would help Medical Device Industries to develop devices which are innovative and in sync with emerging trends.

Our Services

Techflakes Medical Device Industry Offerings

Digital Engineering Consulting

Digital Transformation ROI & Business Case

Digital Product Development (DPD)

New Product Introduction (NPI) Digitization

Product Lifecycle Management

Application Lifecycle Management

Digital Manufacturing

Medical Device MBSE labs

Cloud Services

Our Solutions