Regulatory & Quality Consultancy in MedTech and Pharmaceuticals
Home / Regulatory & Quality Consultancy in MedTech and Pharmaceuticals
Regulatory & Quality Consultancy in MedTech and Pharmaceuticals
Home / Regulatory & Quality Consultancy in MedTech and Pharmaceuticals
Business Support
MedTech (Medical Devices and IVDs) Regulatory Consultancy
We offer support at all business levels: Regulatory Director/Manager/Associate/Specialist Roles
- Regulatory Strategy Development
- Regulatory Gap Analysis
- MDD to MDR (2017/745) and IVD to IVDR (2017/746) transition support
- US FDA medical device consulting (510(k), PMA, ANDA, e-CTD
- Product Commercialisation by supporting the following tasks: Technical Document (TD) Development and Compilation, CE marking, UKCA marking, Global registrations
- Regulatory Change Management and Compliance Support
- Remediation services including process deficiencies, non-conformities, reports, Corrective and Preventative Action plan, and execution
- Support with Design History File review
- Support Post-Market Surveillance (PMS) and Pharmacovigilance (PV) activities
Market Access
Quick and Smooth Access to Global Markets (Registrations)
We have track records of product registrations for both Medical Devices and IVDs across the globe including. We are experts in managing both direct and distributor markets.
- EU
- USA and Canada
- LATAM (Brazil, Mexico,Columbia, Uruguay)
- Russia
- China and Taiwan
- APJ Markets - Japan, Indonesia, Thailand, South Korea, Malaysia and Singapore
- India
- Australia and New Zealand
- Middle East (UAE, Saudi, Dubai, Bahrain, Israel) and Africa – South Africa and Nigeria
Pro-Business Consulting
Our Services
Discover more about the services we have to offer and how we can help your company.
Pro-Business Consulting
Our Services
Discover more about the services we have to offer and how we can help your company.
Medical Device Manufacturers
Medical Device Quality Consultancy
It is particularly important for manufacturers in the MedTech industry to demonstrate and document their ability to provide products that consistently meet their intended purpose and regulatory requirements throughout the whole product lifecycle in line with quality requirements set out in ISO 13485.
In addition to managing risks, ISO 14971 provides an internationally recognised risk management strategy and standard for the MedTech industry, by reducing product risk to all stakeholders, and ensuring compliance with regulations, bringing the device to the market safely.
We can offer ISO 13485 and ISO 14971 Gap Analysis and support in the implementation and certification process.
We also provide support with audits (both preparation and leading audits) with Notified Bodies and Competent Authorities.
Quality Consultancy
ISO Implementation
ISO certification confirms that a business’ management system, processes and documentation meet all the requirements for providing standardised and quality assured products or services.
ISO 9001 sets out the requirements for a Quality Management System (QMS) and can be used by any organisation regardless of its field of business.
As a quality consultancy, we offer support with the implementation, certification, and maintenance of:
- ISO9001 Quality Management System
- ISO27001 Information Security Management
- ISO22301 Business Continuity Management
- ISO/IEC17025 Standard for Testing and Calibration Laboratories
We also provide support with Standard Gap Analysis and both internal and supplier auditing, MDASP and other Notified Body Audits.
Testimonials
What Our Clients Say
At Pro-Business Consulting we provide end to end support to small, medium, and large organisations globally. Check out our testimonials to learn more about our clients’ experiences with us.
