Our services
If you have a challenge or simply need SME or support to improve your processes, you’ll be sure to get the best assistance with ImproveMatic.
Please contact us to get more information’s about the services we can provide.
Quality & Compliance
- The right level of requirements & compliance
- Removing overprocess ing & complexity
- Operational tasks/Critical staff
Manufacturing & Operation
- Linking your business on an Operational level
- Robust, holistic planning for timely execution
- Operational tasks/Critical staff
Digital Readiness
- Bringing vision to life with Quality by Simplicity
- Setting the right Quality Strategy
- Operational tasks/Critical Staff
Quality & Compliance
Experts within ISO13485, ISO14971, ISO9001, ISO19011, IVDR, MDR, MDSAP, 21CFR part 210, 211, 820 & 11, EudraLex vol. 4,
- Establishment, optimization & simplification of Quality Management Systems, Compliance & Production processes
- Implementation of new/updated guidelines and regulations, GAP analysis, setting the strategy to mitigate the GAPs short and long term
- Handling & approval of Quality documents
- GAP analysis, Root cause investigations, Non-conformities, CAPA, Validation, Qualification
- Training, including digitalization of training and establishing LMS
- Post Market Surveillance, Vigilance and Complaint Handling
- Quality Supplier Management, Supplier Audits, CMO Management & Quality agreements
- Mock & internal audits, Inspections & Audits readiness and follow up
- Operational tasks/ Critical staff
Manufacturing & Operation
- Manufacturing Support: Validation, optimization etc. Qualification and Validation
Process optimization - Pilot Production and upscale
- GAP analysis, Root cause investigations, Non-conformities, CAPA
- Cleaning processes
- Procedure and documentation support
- Tech transfer internally & externally
- In connection to introduction of new technologies, rebuild, upgrade green field projects etc: Preparing for realize phase
Mapping & Managing level of details for project execution
Readiness for license to operate
Design & Operational input
Ensure user friendly solutions
Strategy & handling qualification and/or validation activities - Operational tasks/ Critical staff
Digital Readiness
- Mapping & Evaluation of digital maturity & readiness within Quality Assurance and end-user perspective
- Mapping processes, identifications of Q-requirements, operational requirements, gabs, actions and implementing solutions to ensure digital readiness
- Ensuring User friendly solution, compliance & Q implementation strategy e.g.EBR
QMS systems & flow
E-training & Learning Management System (LMS) - Operational tasks/ Critical staff