Protected: JAKSCH LIFESCIENCE CONSULTING (JLSC) Consultation Services for Regulatory and Quality Management Compliance for Medical Devices and IVDs
JAKSCH LIFESCIENCE CONSULTING (JLSC) provides consultation services to medical device companies to ensure regulatory compliance for product registration applications and market access.
The company’s experience with quality management systems (QMS) and risk management allows continued support throughout a product’s lifecycle, ensuring conformity with international medical device and in-vitro diagnostics (IVD) regulations.
JLSC helps guide clients through complex regulatory environments to find a customised solution that meets and exceeds requirements.
Quality management system (QMS) auditing services
JLSC provides first-party and second-party quality management system (QMS) audits to ensure processes meet good manufacturing practice (GMP) requirements and global regulations in countries such as Australia, Brazil, Canada, China, the US, the EU and Japan.
These audits also ensure that clients’ products are effective and safe, that a QMS is established and maintained and that suppliers are meeting contract requirements such as sterilisation and packaging. The service covers auditing of design dossiers and technical files, due diligence audits and full audit solution management.
In addition, JLSC has an in-depth understanding of the requirements of the relevant competent authorities and certification bodies that undertake third-party audits, which is incorporated into its training, coaching and mentoring.
Supplier quality management services
JLSC’s supplier quality management services (SQM) help medical device companies navigate complex supply chains and ensure the processes comply with international regulatory requirements.
The company helps organise and risk-grade suppliers, implements contracts and quality assurance (QA) agreements, conducts second party supplier audits to meet global regulations and processes audit findings, complaints and supplier corrective action requests (SCAR).
CAPA and NC complaint handling solutions
JLSC offers a wide range of solutions for handling non-conformity (NC) complaints and corrective and preventive action (CAPA) for medical device products.
The company’s complaint-handling services include establishing complaints procedures; documenting, investigating, assessing and remedying complaints; investigating the root cause of quality deviations; and implementing CAPA measures according to national laws and regulations.
Meeting disinfection requirements and sterility assurance for manufacturing applications
JLSC works closely with manufacturers of products intended to disinfect medical devices, hand disinfectants and single-use brushes and sponges to meet medical device directives (MDD) in Europe such as the Medicinal Directive and the Biocide Products Directive.
The company helps clients establish cleaning and disinfection processes procedures and documentation for sterile and non-sterile products, including selecting a suitable sterilisation method based on product material, packaging and risk management requirements.
It also supports the validation of QA processes in regular and cleanroom manufacturing; validates disinfected processing equipment; establishes a regulatory strategy for disinfectants and manages decontamination procedures for products returned for investigation.
In addition, the firm supports speciality cleaning validation procedures such as the formation of sampling plans for in-process testing of finished products and the support of consistent manufacturing processes in regards to in-process hold times and endotoxin-removal steps to ensure pyrogen-free medical devices and IVDs.
Sterility support and risk management in formulation, packaging and clinical reprocessing
JLSC provides sterility support for all stages of a product’s lifecycle, including development, packaging processes and clinical reprocessing.
Water is often used as a carrier for active pharmaceutical ingredients (API) and as an analytical reagent for cleaning processes. JLSC supports the selection of high-quality water sources, as well as plans and validates purification and treatment processes.
Within packaging development, the company helps support pack designs to meet FDA 21 CFR 820.130 and ISO 11607 requirements through process development and in-process testing.
JLSC creates the necessary procedures to meet international clinical reprocessing regulatory requirements, executing risk-management assessments and supporting the validation of reprocessing procedures in hospitals.
MA applications, patents and IP services for medical device manufacturers
JLSC is experienced in the highly regulated medical device and IVD industries and understands the stringent regulatory requirements of these sectors worldwide. The company works closely with clients to prepare their products for MA and patent applications, supporting the creation of the necessary documentation.
The company manages legislation gap assessment, regulatory affairs support during product development, global registration of medical devices and IVDs, maintenance of summary technical documents (STED) and common submission dossier templates (CSDT), and the acquisition of notarizations.
JLSC’s intellectual property (IP) services include the development of an IP strategy, conducting IP searches and supports applications IP protection.
Labelling and unique device identification (UDI) services
JLSC supports medical devices and IVDs to comply with international labelling requirements, preventing penalties for noncompliance.
The firm’s labelling services include establishing an e-labelling and labelling strategy, gap assessment, establishment of speciality labels such as investigational device labels, and creating instructions for use (IFU), fact sheets and advertising materials.
To ensure product traceability, JLSC establishes unique device identification (UDI) compliant labels and validates all tools and apparatus required for label printing.
Post-market surveillance (PMS) and post-market clinical follow-up (PMCF)
JLSC provides post-market surveillance (PMS) and post-market clinical follow-up (PMCF) services for medical device and IVD products. It develops custom strategies and updates the strategy to ensure continued compliance with changing regulatory requirements.
The company also establishes tools for the effective use of PMS and PMCF data for risk management, as well as trains employees and stakeholders on procedures and processes.
Project management and interim management services
JLSC provides services for efficient time and resources management to help products achieve market access. The firm’s project managers lead project teams and handle budgeting and communication. In addition, JLSC’s interim managers take temporary economic responsibility or leadership responsibility for a client’s department or business area until new leadership can be established.
Risk management and due diligence assessments
JLSC’s risk management strategies ensure that clients’ products are safe and effective throughout the entire product lifecycle. These services involve legislation gap assessment and the planning, organising and conducting of risk assessments.
In addition, JLSC provides due diligence risk assessments to ensure a new business unit meets economic, legal, tax and financial conditions. The company assesses competitors, leads due-diligence teams and audits affected organisations or operating units.
Mergers and acquisitions (M&A) management
JLSC provides intrinsic strategic management for mergers and acquisitions (M&A) projects. The company helps reorganise the merged entities to support product and knowledge transfer, legal compliance and remediation of quality systems, procedures and supply chains.
The firm also offers audits of affected parties and creates change notifications to international regulatory authorities.