PROJECT AND INTERIM MANAGEMENT FOR THE DEPARTMENTS OF QUALITY MANAGEMENT, REGULATORY AFFAIRS AS WELL AS SALES AND MARKETING IN MEDICAL TECHNOLOGY, IN VITRO DIAGNOSTICS AND LIFE SCIENCES

PROJECT AND INTERIM MANAGEMENT ACCORDING TO YOUR NEEDS

In the course of our project management activities we are steering ad interim also cross-functional teams in order to meet project goals on time. Project management is performed according to your requirements in a classical, agile or hybrid manner. For our work we use well established concepts and best practices to achieve optimum results. Associated project risks are analyzed, assessed and finally risk management measures are implemented.
In the fields of interim management and take-over of corporate functions CONSILIO ET OPERA GMBH specializes in the areas of quality management, regulatory affairs, sales and marketing as well as strategic business unit management.

IN QUALITY MANAGEMENT

CONSILIO ET OPERA supports manufacturers of medical devices and their distributors (e.g. manufacturers of inorganic basic chemicals, fine and specialty chemicals and companies of the metal and electrical industry) to implement, maintain and further develop their quality management system (QMS) according to regulatory requirements, relevant guidance documents and international standards. Our services include:

Initial implementation of a lean QMS based on ISO 9001, ISO 13485, MDR, IVDR, FDA 21 CFR Part 820 or Medical Device Single Audit Program (MDSAP)
Development of resource-saving integrated management systems (e.g., ISO 9001, ISO 14001 and / or ISO 50001)
Resource-saving integration of management systems (e.g., ISO 9001 and ISO 14001)
Transfer from a QMS based on ISO 9001 to ISO 13485
Maintenance of the QMS documentation
Streamlining processes by using the lean management approach
Definition of quality objectives to support quality policy
Integration of risk management based on ISO 14971 into QMS
Risk based validation and revalidation of software used in QMS
Preparation and support of external audits according to ISO 13485, MDSAP, ISO 14001 or ISO 50001
Carrying out internal audits and supplier audits
Processing of complaints, deviations as well as corrective and preventive actions (CAPA)
Management of changes and cases, when outsourced products are out of specifications (OOS)
Support in setting up management reviews (e.g., surveillance and measuring of processes and products (quality metrics)
Qualification and management of suppliers

IN REGULATORY AFFAIRS

In the sector of regulatory affairs CONSILIO ET OPERA GMBH supports your enterprise particularly to meet the requirements of EU MDR (REGULATION (EU) 2017/745), EU IVDR (REGULATION (EU) 2017/746), FDA (listing, 510k clearance, PMA approval), MHRA and Swissmedic. Our services comprise:

Conduct of gap analyses and assessments with regards to the fulfilment of regulatory requirements relevant for the conformity assessment / registration of a medical device or in vitro diagnostic medical device
Compilation and maintenance of documents for conformity assessments / registrations (e.g., technical documentation)
Communication on regulatory topics with internal (e.g., from Project Management, R&D, Manufacturing, Marketing, Quality Management, Clinical Affairs) and external (e.g., from notified bodies, local authorities) contact persons
Preparing recommendations on the product enrolment / registration strategy
Assessment of claims made about medical devices / in vitro diagnostic medical devices and assurance of their compliant application / communication
Administrative preparation (support) of clinical / performance evaluations, clinical investigations and performance studies
Carrying out of post market surveillance activities (e.g., PMS Plan, PMS Report, PMCF Plan, PMCF Report, PSUR, update of clinical evaluation / performance evaluation)
Maintenance of the risk management system (e.g., based on ISO 14971 )
Support of vigilance topics
Maintenance of regulatory databases (e.g., EUDAMED, FDA-GUDID)
Performing tasks and obligations as person responsible for regulatory compliance (PRRC) in accordance with article 15 MDR / IVDR for micro and small enterprises

IN SALES AND MARKETING

CONSILIO ET OPERA’s offer with regards to sales and marketing covers :

Execution of product management tasks
Management of product launches
Planning, implementation and control of the marketing mix (4P+)
Management of sales process
Development of sales strategy and implementation of appropriate tools to support underlying measures with sales representatives
Set-up of sales and marketing budget plans
Steering and coaching of sales and marketing team
Establishment and maintenance of long-term customer relationships
Planning, implementation and control of sales activities
Restructuring of sales territories

IN STRATEGIC BUSINESS UNIT MANAGEMENT

When taking over a strategic business unit the services of CONSILIO ET OPERA include:

Responsibility for the day-to-day business (including revenues and earnings)
Analysis and further development of business unit’s the overall strategy
Planning of resources to meet the company objectives
Identification and development of profitable new market segments
Optimization of business processes also aiming at lean administration and lean production
Implementation and management of cross-functional teams to tackle challenging project tasks

YOUR GOALS ARE OUR MISSION

YOUR GOALS ARE OUR MISSION

CONSILIO ET OPERA GUARANTEES

WARRANTY OF CONFIDENCE

If your company has signed a service contract and is not a 100% satisfied with our performance, it is free to terminate it with immediate effect.

TELEPHONE SUPPORT

Once your company has given a mandate for consulting or project / interim management it will receive a voucher for 2 hours of telephone consultation in addition to each weekly working contingent (40 hours) ordered. A voucher can be redeemed within one year of issue.

OUR QUALITY MANAGEMENT SYSTEM

PERSONNEL SEARCH

Our strategic alliance partners include independent personnel agencies and freelancers. This offers you the advantage that we can support your personnel search through our network also when you are dealing with large projects. The precondition for this, however, is that our company will be engaged in the same project as these additional external human resources.