Projects:
BIONDEC Consulting
Strategic consultancy specialized in new products for companies in the Medical Devices Business.
About Us
History
Biondec begins as a startup mentored by Polytechnic University of Valencia (UPV) with the aim of facilitating technological innovation in the medical device business.
With this purpose it helps companies responsible for the design and manufacturing (overall Pymes and Startups) on ensuring that their new products are safe for patients and users in accomplishment with regulation and on finding the optimum and agile solution.
With more than 15 years of experience on Quality in multinational environments and specializing on new product introduction (from development to commercialization).
We offer solutions and if we do not have the expertise, we connect with the experts needed to execute the project.
Mission
Our mission is to make new technologies more accessible to patients and users by collaborating to find the most optimal solution for designers and manufacturers in compliance with the Regulation.
As part of our mission, we share knowledge with the goal of being critical with information and finding applications that benefit society, through consulting, training, and scientific dissemination.
Values
- Ethics, reliability and credibility are part of our core values.
- Results-oriented and compromised with the objectives.
- We contribute to sustainability through reduction of waste and promoting electronic documentation.
- We collaborate on Equality by helping to make products more accessible to most of society.
Services
Strategic Consulting
Strategic consultancy specializing in development, industrialization and commercialization of new products on Quality and Regulatory Compliance subjects for companies in the Medical Devices Business.
Consulting Services:
- Providing advice on Quality and Regulatory Compliance, Training (online and on-site)
- Workshops
- R&D and Industrialization
- Support for R&D in collaboration with Technological Institutes and Universities
- Documentation for submissions to Notified Bodies.
- Implementation of ISO 13485.
- New products development and Technology Transfer / Industrialization.
Specific subjects:
- Design validation and controls.
- Strategies for qualification and validation of equipment and processes (PVPs, IQ, OQs and PQs).
- Establishment of controls and monitoring for manufacturing.
- Sterility Assurance
- Qualification and control of Clean Rooms
- Management of Non-conformities, Corrective and Preventive Actions (CAPAs), Complaints.
- Change control and deviations.
- Providers and third parties’ audits.
- KPIs and management review.
Balanced Scorecard, Dashboards, Digitalization
We offer training adapted to our clients’ needs, such as:
- Implementation of ISO 13485
- Steps for new product introduction (from Concept to Commercialization)
- Problem Solving and Corrective and Preventive Actions (CAPAs)
- Tools for Root Cause Analysis
- Equipment and/or Process Validation
- Balanced scorecards, Dashboards.
We lead and/or support preparing workshops on subjects such as the following ones:
- Preparing and leading workshops related to R&D and Quality.
- We support ideas generation and selecting actionable projects.
- Facilitating the establishment of departmental objectives aligned with the corporate objectives of the client’s company.
- Problem Solving
Products
Online training courses, software and digital solutions
Online training courses
We develop standard training courses.
Software and digital solutions
We connect with the best solution according to our client’s needs and we are developing new solutions.
Please contact us through the following email to receive additional information email info@biondec.com
Media and News
Media
Content on innovation, quality, new technologies and scientific dissemination.
